ClearanceBrief
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

ApplicantTerumo Cardiovascular Systems Corp., Ann Arbor MI, US
DecisionSubstantially Equivalent, Mar 20, 2003
ReceivedSep 5, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K022947

DateFirm and productCodeLinked 510(k)
May 28, 2015Terumo 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
DTQNone listed
May 28, 2015Terumo 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
DTQNone listed
Jul 8, 2014Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Terminated
DTQNone listed
Jul 8, 2014Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Terminated
DTQNone listed
Aug 15, 2013Terumo 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
DTQNone listed
Aug 15, 2013Terumo 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
DTQNone listed
Aug 14, 2013Terumo 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
DTQNone listed
Aug 14, 2013Terumo 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
DTQNone listed
Aug 14, 2013Terumo 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
DTQNone listed
Aug 14, 2013Terumo 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
DTQNone listed
Nov 27, 2012Terumo 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
DTQNone listed
Nov 27, 2012Terumo 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
DTQNone listed
Sep 25, 2012Terumo 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
DTQNone listed
Sep 24, 2012Terumo 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
DTQNone listed
Aug 21, 2012Terumo 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
DTQNone listed
Aug 21, 2012Terumo 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
DTQNone listed
Aug 21, 2012Terumo 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
DTQNone listed
Aug 21, 2012Terumo 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
DTQNone listed
Aug 9, 2012Terumo 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
DTQNone listed
Aug 9, 2012Terumo 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
DTQNone listed
Jul 20, 2012Terumo 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
DTQNone listed
Jul 20, 2012Terumo 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
DTQNone listed
Jul 19, 2012Terumo 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
DTQNone listed
Jul 19, 2012Terumo 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
DTQNone listed
Jul 17, 2012Terumo 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
DTQNone listed
Jul 17, 2012Terumo 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
DTQNone listed
Jul 13, 2012Terumo 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
DTQNone listed
Jul 13, 2012Terumo 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
DTQNone listed
Jul 9, 2012Terumo 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
DTQNone listed
Jul 9, 2012Terumo 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
DTQNone listed
Jul 9, 2012Terumo 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
DTQNone listed
Jul 9, 2012Terumo 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
DTQNone listed
Jul 9, 2012Terumo 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
DTQNone listed
Jul 9, 2012Terumo 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
DTQNone listed
Jul 9, 2012Terumo 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
DTQNone listed
Jul 9, 2012Terumo 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
DTQNone listed
Jul 9, 2012Terumo 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
DTQNone listed
Jul 6, 2012Terumo 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
DTQNone listed
Jul 6, 2012Terumo 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
DTQNone listed
Mar 27, 2012Terumo 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
DTQNone listed
Mar 27, 2012Terumo 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
DTQNone listed
Jan 24, 2012Terumo 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
DTQNone listed
Jan 24, 2012Terumo 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
DTQNone listed
Nov 29, 2011Terumo 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
DTQNone listed
Nov 29, 2011Terumo 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
DTQNone listed
Nov 29, 2011Terumo 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
DTQNone listed
Nov 29, 2011Terumo 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
DTQNone listed
Nov 29, 2011Terumo 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
DTQNone listed
Jul 6, 2011Terumo 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
DTQNone listed
Jul 6, 2011Terumo 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
DTQNone listed
Jul 6, 2011Terumo 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
DTQNone listed
Jun 22, 2011Terumo 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
DTQNone listed
Jun 22, 2011Terumo 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
DTQNone listed
Jun 22, 2011Terumo 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
DTQNone listed
Jun 22, 2011Terumo 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
DTQNone listed
Jun 22, 2011Terumo 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
DTQNone listed
Jun 22, 2011Terumo 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
DTQNone listed
Jun 22, 2011Terumo 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
DTQNone listed
Jun 22, 2011Terumo 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
DTQNone listed
Jun 22, 2011Terumo 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
DTQNone listed
Mar 7, 2011Terumo 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
DTQNone listed
Mar 7, 2011Terumo 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
DTQNone listed
Jan 7, 2011Terumo 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
DTQNone listed
Sep 23, 2010Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1, Catalog number 801763, 100/120V System 1 base, Terumo Cardiovascular System, Ann Arbor MI.
Terminated
DTQNone listed
Sep 23, 2010Terumo 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
DTQNone listed
May 29, 2009Terumo 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
DTQNone listed
Feb 24, 2009Terumo 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
DTQNone listed
Feb 24, 2009Terumo 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
DTQNone listed
Jan 29, 2009Terumo 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
DTQNone listed
Jan 29, 2009Terumo 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
DTQNone listed
Jan 29, 2009Terumo 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
DTQNone listed
Jan 29, 2009Terumo 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
DTQNone listed
Jan 29, 2009Terumo 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
DTQNone listed
Dec 29, 2008Terumo 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
DTQNone listed
Dec 29, 2008Terumo 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
DTQNone listed
Dec 11, 2008Terumo 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
DTQNone listed
Dec 11, 2008Terumo 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
DTQNone listed
Dec 11, 2008Terumo 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
DTQNone listed
Dec 11, 2008Terumo 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
DTQNone listed
Nov 25, 2008Terumo 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
DTQNone listed
Nov 25, 2008Terumo 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
DTQNone listed
Nov 6, 2008Terumo 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
DTQNone listed
Nov 6, 2008Terumo 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
DTQNone listed
Oct 31, 2008Terumo 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
DTQNone listed
Oct 31, 2008Terumo 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
DTQNone listed
Jan 24, 2008Terumo 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
KRLNone listed
Jan 24, 2008Terumo 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
KRLNone listed
Jan 24, 2008Terumo 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
KRLNone listed
Dec 1, 2007Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
Terminated
DTQNone listed
Dec 1, 2007Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System, 1 Roller Pump, 6 inch diameter; Catalog No. 801041, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
Terminated
DTQNone listed
Dec 1, 2007Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number 801046, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
Terminated
DTQNone listed
Jun 30, 2007Terumo 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
DTQNone listed
Jun 30, 2007Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1, 4 inch diameter (small) Roller Pump; Model 801040.
Terminated
DTQNone listed
Jun 30, 2007Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1, 6 inch diameter (Large) Roller Pump; Model 801041.
Terminated
DTQNone listed
Jun 30, 2007Terumo 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
DTQNone listed
Jun 30, 2007Terumo 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
DTQNone listed
Jun 30, 2007Terumo 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
DTQNone listed
Jun 30, 2007Terumo 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
DTQNone listed
Jun 30, 2007Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Terminated
DTQNone listed
Jun 30, 2007Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
Terminated
DTQNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.