Panels › Cardiovascular › Product code DTQ · Class 2
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation 870.4220
0510(k)s in 12 months (52 all time)
1recalls in 12 months (267 all time)
257recalls that name a 510(k)
Top companies in DTQ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| Apr 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pressure Board, Arterial Monitor (service part only)
The 8K Arterial Monitor is intended for use with the 8000 Terminated |
DTQ | K915183 |
| Apr 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board, Cardioplegia Monitor (service part only)
The 8K Arterial Monitor is intended for use with the 8 Terminated |
DTQ | K915183 |
| Apr 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Modular Perfusion System 8000 Catalog number 16413 Arterial Monitor
The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three Terminated |
DTQ | K915183 |
| Apr 23, 2012 | Terumo Cardiovascular Systems Corporation Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor
The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and thr Terminated |
DTQ | K915183 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH Sorin C5 (perfusion system)
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | K093882 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH Control panel for mast roller pump 85
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | K071318 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH Control panel for mast roller pump 150/85
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | K071318 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH S5 Double Roller Pump 85
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | K071318 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH S5 Single Roller Pump 150
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | K071318 |
| 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 | K022947 |
| 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 | K022947 |
| Mar 5, 2012 | Sorin Group USA, Inc. SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA
The S5 System is used to Terminated |
DTQ | K060053 |
| Mar 5, 2012 | Sorin Group USA, Inc. SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SDR S5 MAST ROLLER PUMP 85, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-70
The S5 System is used to perform, Terminated |
DTQ | K060053 |
| Mar 5, 2012 | Sorin Group USA, Inc. SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, S5 TWO MAST PUMPS 85 W/ COUPLING, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-62
The S5 System is used to per Terminated |
DTQ | K060053 |
| Mar 5, 2012 | Sorin Group USA, Inc. SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 TWO MAST ROLLER PUMPS, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-60
The S5 System is used to perform Terminated |
DTQ | K060053 |
| Mar 5, 2012 | Sorin Group USA, Inc. SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 MAST ROLLER PUMP, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-00
The S5 System is used to perform, con Terminated |
DTQ | K060053 |
| Mar 5, 2012 | Sorin Group USA, Inc. S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 8000 Terminated |
DTQ | K060053 |
| Mar 5, 2012 | Sorin Group USA, Inc. S5/C5 control panel for mast roller pump 150/85, Part No.: 28-95-80, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 800 Terminated |
DTQ | K060053 |
| Mar 5, 2012 | Sorin Group USA, Inc. Stockert S5 Control and display module, Part No.: 28-95-10, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA
Terminated |
DTQ | K060053 |
| Mar 5, 2012 | Sorin Group USA, Inc. Stockert, S5 Double roller pump 85, Part 10-85-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA
The S5 Sy Terminated |
DTQ | K060053 |
| Mar 5, 2012 | Sorin Group USA, Inc. Stockert, S5 Roller pump 150, Part 10-80-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA
The S5 System i Terminated |
DTQ | K060053 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| Aug 29, 2011 | Maquet Inc. Maquet HL Console for Heart Lung Machine HL20
HL 20 4-pumps console base: P/N 917741
HL 20 5-pumps console base: P/N 917751
Intended for use as an extracorporeal circulation device for perfusion last Terminated |
DTQ | K943803 |
| Aug 22, 2011 | Maquet Inc. Maquet HL Console for Heart Lung Machine HL20:
HL 20 4-pumps console base: P/N 917741
HL 20 5-pumps console base: P/N 917751
The HL 20 is indicated for use as an extracorporeal circulation device for Terminated |
DTQ | K943803 |
| Jul 6, 2011 | Terumo Cardiovascular Systems Corporation Large Roller Pump 6" Diameter, Catalog 801041, 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 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 K871131 +1 |
| 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 | K022947 K871131 +1 |
| 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 | K022947 K871131 +1 |
| 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 | K022947 K871131 +1 |
| 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 | K022947 K871131 +1 |
| 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 | K022947 K871131 +1 |
| 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 | K022947 K871131 +1 |
| 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 | K022947 K871131 +1 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.