510(k) K022947 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Mar 20, 2003 |
| Received | Sep 5, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022947
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2015 | Terumo Cardiovascular Systems Corporation 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, r Terminated |
DTQ | None listed |
| May 28, 2015 | Terumo Cardiovascular Systems Corporation Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, r Terminated |
DTQ | None listed |
| Jul 8, 2014 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1
100/120V AC, Advanced Perfusion System
Platform (APS) Terminated |
DTQ | None listed |
| Jul 8, 2014 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1
220/240V AC, Advanced Perfusion System
Platform (APS) Terminated |
DTQ | None listed |
| Aug 15, 2013 | Terumo Cardiovascular Systems Corporation 100/120V AC, Advanced Perfusion System 1
Product Usage:
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, Terminated |
DTQ | None listed |
| Aug 15, 2013 | Terumo Cardiovascular Systems Corporation 220/240V AC, Advanced Perfusion System 1
Product Usage:
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, Terminated |
DTQ | None listed |
| Aug 14, 2013 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, Terminated |
DTQ | None listed |
| Aug 14, 2013 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion Terminated |
DTQ | None listed |
| Aug 14, 2013 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 (APS1, System 1)
100/120V AC
Product Usage:
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusio Terminated |
DTQ | None listed |
| Aug 14, 2013 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 (APS1, System 1)
Description: 220/240V AC
Product Usage:
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arte Terminated |
DTQ | None listed |
| Nov 27, 2012 | Terumo Cardiovascular Systems Corporation 100/120V AC, Advanced Perfusion System Platform (APS)
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, Terminated |
DTQ | None listed |
| Nov 27, 2012 | Terumo Cardiovascular Systems Corporation 220/240V AC, Advanced Perfusion System Platform (APS)
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, Terminated |
DTQ | None listed |
| Sep 25, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Flow Module
indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when use Terminated |
DTQ | None listed |
| Sep 24, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD
Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional Terminated |
DTQ | None listed |
| Aug 21, 2012 | Terumo Cardiovascular Systems Corporation Serial interface module RS-232
Product Usage:
The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is Terminated |
DTQ | None listed |
| Aug 21, 2012 | Terumo Cardiovascular Systems Corporation Serial interface module RS-485
Product Usage:
The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is Terminated |
DTQ | None listed |
| Aug 21, 2012 | Terumo Cardiovascular Systems Corporation Interface module for CDl System 100/101
Product Usage:
The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Commu Terminated |
DTQ | None listed |
| Aug 21, 2012 | Terumo Cardiovascular Systems Corporation Interface module for CDl System 500
Product Usage:
The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communica Terminated |
DTQ | None listed |
| Aug 9, 2012 | Terumo Cardiovascular Systems Corporation System 1 base 100/120V
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass proced Terminated |
DTQ | None listed |
| Aug 9, 2012 | Terumo Cardiovascular Systems Corporation System 1 base 220/240V
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass proced Terminated |
DTQ | None listed |
| Jul 20, 2012 | Terumo Cardiovascular Systems Corporation System 1 Base 100/120V
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiop Terminated |
DTQ | None listed |
| Jul 20, 2012 | Terumo Cardiovascular Systems Corporation System 1 Base 220/240V
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiop Terminated |
DTQ | None listed |
| Jul 19, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1. System 1 base 100/120V.
The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfus Terminated |
DTQ | None listed |
| Jul 19, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1. System 1 base 220/240V.
The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfus Terminated |
DTQ | None listed |
| Jul 17, 2012 | Terumo Cardiovascular Systems Corporation System 1 Base, 100/120V.
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardi Terminated |
DTQ | None listed |
| Jul 17, 2012 | Terumo Cardiovascular Systems Corporation System 1 Base, 220/240V.
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardi Terminated |
DTQ | None listed |
| Jul 13, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1
System 1 Base, 100/120V.
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perf Terminated |
DTQ | None listed |
| Jul 13, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1
System 1 Base, 220/240V.
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perf Terminated |
DTQ | None listed |
| Jul 9, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1
Electronic O2 Blender/Analyzer.
The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenato Terminated |
DTQ | None listed |
| Jul 9, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1
System 1 Base, 100/120V.
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perf Terminated |
DTQ | None listed |
| Jul 9, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1
System 1 Base, 220/240 V.
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial per Terminated |
DTQ | None listed |
| Jul 9, 2012 | Terumo Cardiovascular Systems Corporation System 1 Base, 100/120V
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardi Terminated |
DTQ | None listed |
| Jul 9, 2012 | Terumo Cardiovascular Systems Corporation System 1 Base, 220/240V
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardio Terminated |
DTQ | None listed |
| Jul 9, 2012 | Terumo Cardiovascular Systems Corporation System 1 Base 100/120V
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiop Terminated |
DTQ | None listed |
| Jul 9, 2012 | Terumo Cardiovascular Systems Corporation System 1 Base 220/240V
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiop Terminated |
DTQ | None listed |
| Jul 9, 2012 | Terumo Cardiovascular Systems Corporation System 1 Base 100/120V
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiop Terminated |
DTQ | None listed |
| Jul 9, 2012 | Terumo Cardiovascular Systems Corporation System 1 Base 220/240V.
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardio Terminated |
DTQ | None listed |
| Jul 6, 2012 | Terumo Cardiovascular Systems Corporation Central Control Module for System 1: System 1 Base, 100/120V
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perf Terminated |
DTQ | None listed |
| Jul 6, 2012 | Terumo Cardiovascular Systems Corporation Central Control Module for System 1: System 1 Base, 220/240V
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perf Terminated |
DTQ | None listed |
| Mar 27, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Base, 100/120V, Catalog 801763, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. Indicated for use for up to 6 hours on the extracorporeal circulation of blood f Terminated |
DTQ | None listed |
| Mar 27, 2012 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood f Terminated |
DTQ | None listed |
| Jan 24, 2012 | Terumo Cardiovascular Systems Corporation Roller Pump, 4 Inch Diameter
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and c Terminated |
DTQ | None listed |
| Jan 24, 2012 | Terumo Cardiovascular Systems Corporation Roller Pump, 6 Inch Diameter
The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and c Terminated |
DTQ | None listed |
| Nov 29, 2011 | Terumo Cardiovascular Systems Corporation The Terumo Advanced Perfusion System 1, Catalog Number 801763, System 1 Base, 110 V
Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circu Terminated |
DTQ | None listed |
| Nov 29, 2011 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray)
Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circu Terminated |
DTQ | None listed |
| Nov 29, 2011 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1
Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulatio Terminated |
DTQ | None listed |
| Nov 29, 2011 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1
Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation Terminated |
DTQ | None listed |
| Nov 29, 2011 | Terumo Cardiovascular Systems Corporation The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V
Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circul Terminated |
DTQ | None listed |
| Jul 6, 2011 | Terumo Cardiovascular Systems Corporation System 1 Base 110V, Catalog 801763, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI
The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regi Terminated |
DTQ | None listed |
| Jul 6, 2011 | Terumo Cardiovascular Systems Corporation System 1 Base 220V, Catalog 801764, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI
The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regi Terminated |
DTQ | None listed |
| Jul 6, 2011 | Terumo Cardiovascular Systems Corporation Large Roller Pump 6" Diameter, Catalog 816571, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI
The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial per Terminated |
DTQ | None listed |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer. Terminated |
DTQ | None listed |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kit Part number 70667-01 Eisenhower Army Med Center Heart Lung Pack, Sterile, Terumo Cardiovascular Systems Ashland, MA. The pressure monitoring kit is indicated for sterile Terminated |
DTQ | None listed |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kit Part number 70667 Eisenhower Army Med Center Heart Lung Pack, Sterile, Terumo Cardiovascular Systems Ashland, MA. The pressure monitoring kit is indicated for sterile si Terminated |
DTQ | None listed |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kit Part number 70367-07 Mission St. Joe's - Asheville X-Coated Low Prime Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicate Terminated |
DTQ | None listed |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kit Part number 72427, Oklahoma Heart Hospital X-Coated System 1 Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for st Terminated |
DTQ | None listed |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kit, Part number 65418-01, Terumo Latin America Seminsa Pediatric Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for steril Terminated |
DTQ | None listed |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kit, Part number 65672-01, Terumo Latin America Seminsa lactante, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for sterile Terminated |
DTQ | None listed |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kit, Part number 65870, Terumo Latin America Pediatric Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for sterile sing Terminated |
DTQ | None listed |
| Jun 22, 2011 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kit, Part number 65871, Terumo Latin America Lactante Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for sterile singl Terminated |
DTQ | None listed |
| Mar 7, 2011 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporea Terminated |
DTQ | None listed |
| Mar 7, 2011 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1, 220/240V System 1 Base, REF 801764, Terumo Cardiovascular Systems Corp., Ann Arbor, MI. (not sold in the USA)
The Terumo Advanced Perfusion System 1 is indicated fo Terminated |
DTQ | None listed |
| Jan 7, 2011 | Terumo Cardiovascular Systems Corporation Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI.
The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit Terminated |
DTQ | None listed |
| Sep 23, 2010 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1, Catalog number 801763, 100/120V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. Terminated |
DTQ | None listed |
| Sep 23, 2010 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. (This product is not distributed in the US) Terminated |
DTQ | None listed |
| May 29, 2009 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802100.
The Central Control Monitor (CCM) provides a centralized display of sy Terminated |
DTQ | None listed |
| Feb 24, 2009 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763.
The device is indicate Terminated |
DTQ | None listed |
| Feb 24, 2009 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within th Terminated |
DTQ | None listed |
| Jan 29, 2009 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Air Bubble Detection Module, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802110.
For use for up to 6 hours in the extracorporeal circulation of bloo Terminated |
DTQ | None listed |
| Jan 29, 2009 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Pressure Monitoring Unit, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802112.
For use for up to 6 hours in the extracorporeal circulation of blood f Terminated |
DTQ | None listed |
| Jan 29, 2009 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Temperature Monitoring Systems, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802114.
For use for up to 6 hours in the extracorporeal circulation of b Terminated |
DTQ | None listed |
| Jan 29, 2009 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Pressure Venous Occluder, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 803480.
For use for up to 6 hours in the extracorporeal circulation of blood f Terminated |
DTQ | None listed |
| Jan 29, 2009 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump, Terumo Cardiovascular Systems, Ann Arbor, MI; Model 801041.
For use for up to 6 hours in the extracorporeal circulation of blood for ar Terminated |
DTQ | None listed |
| Dec 29, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated |
DTQ | None listed |
| Dec 29, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). Terminated |
DTQ | None listed |
| Dec 11, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model 801040).
Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Terminated |
DTQ | None listed |
| Dec 11, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump; Model 801041).
Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Terminated |
DTQ | None listed |
| Dec 11, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570).
Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass proced Terminated |
DTQ | None listed |
| Dec 11, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump, Gray; Model 816571).
Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass proced Terminated |
DTQ | None listed |
| Nov 25, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusi Terminated |
DTQ | None listed |
| Nov 25, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusi Terminated |
DTQ | None listed |
| Nov 6, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Base, 100/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary by Terminated |
DTQ | None listed |
| Nov 6, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This product is not distributed in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial Terminated |
DTQ | None listed |
| Oct 31, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 base, 110/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary by Terminated |
DTQ | None listed |
| Oct 31, 2008 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States.
For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusio Terminated |
DTQ | None listed |
| Jan 24, 2008 | Terumo Cardiovascular Systems Corp Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5773, Terumo Cardiovascular Systems, Ann Arbor, MI 48103 Terminated |
KRL | None listed |
| Jan 24, 2008 | Terumo Cardiovascular Systems Corp Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Terumo Cardiovalvular Systems, Ann Arbor, MI 48103 Terminated |
KRL | None listed |
| Jan 24, 2008 | Terumo Cardiovascular Systems Corp Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791, Terumo Cardiovascular Systems, Ann Arbor, MI 48103 Terminated |
KRL | None listed |
| Dec 1, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Terumo Cardiovascular Systems, Ann Arbor, MI 48103 Terminated |
DTQ | None listed |
| Dec 1, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System, 1 Roller Pump, 6 inch diameter; Catalog No. 801041, Terumo Cardiovascular Systems, Ann Arbor, MI 48103 Terminated |
DTQ | None listed |
| Dec 1, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number 801046, Terumo Cardiovascular Systems, Ann Arbor, MI 48103 Terminated |
DTQ | None listed |
| Jun 30, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated |
DTQ | None listed |
| Jun 30, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 4 inch diameter (small) Roller Pump; Model 801040. Terminated |
DTQ | None listed |
| Jun 30, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 6 inch diameter (Large) Roller Pump; Model 801041. Terminated |
DTQ | None listed |
| Jun 30, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated |
DTQ | None listed |
| Jun 30, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). Terminated |
DTQ | None listed |
| Jun 30, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated |
DTQ | None listed |
| Jun 30, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). Terminated |
DTQ | None listed |
| Jun 30, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. Terminated |
DTQ | None listed |
| Jun 30, 2007 | Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.