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) |
|---|---|---|---|
| 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 | K022947 K871131 +1 |
| 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 | K022947 |
| 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 | K022947 |
| Feb 22, 2011 | Maquet Cardiovascular Us Sales, Llc Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20. Terminated |
DTQ | K943803 |
| Jan 26, 2011 | Sorin Group USA, Inc. SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004 Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Terminated |
DTQ | K060053 |
| Jan 26, 2011 | Sorin Group USA, Inc. S5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germany, Sorin Group USA, 14401 W. 65th Way, Arvada, CO 80004.
Used to perform, control and monitor ext Terminated |
DTQ | K060053 |
| Jan 26, 2011 | Sorin Group USA, Inc. SRD S5 Mast Roller Pump System 85, S5 Component, Part No.: 50-80-70, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004.
Used to perform, control and monitor extracorporeal blo Terminated |
DTQ | K060053 |
| Jan 26, 2011 | Sorin Group USA, Inc. 2 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004.
Used to perform, control and monitor extraco Terminated |
DTQ | K060053 |
| Jan 26, 2011 | Sorin Group USA, Inc. SRD S5 Mast Roller Pump System 150, S5 Component, Part No.: 50-80-00, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004.
Used to perform, control and monitor extracorporeal bl Terminated |
DTQ | K060053 |
| Jan 26, 2011 | Sorin Group USA, Inc. S5 Control Panel for 2 Mast Roller Pumps 85, Part No.: 28-95-85, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004.
Used Terminated |
DTQ | K060053 |
| Jan 26, 2011 | Sorin Group USA, Inc. S5 Mast Roller Pump System 85, Part No.: 28-95-80, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004.
Used to perform, co Terminated |
DTQ | K060053 |
| Jan 26, 2011 | Sorin Group USA, Inc. S5 Display and Control Module, Part No.: 28-95-10, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany.
Used to perform, control and monitor extracorporeal blood circulation during an Terminated |
DTQ | K060053 |
| Jan 26, 2011 | Sorin Group USA, Inc. Stockert, S5 Double Roller Pump 85, Part No.: 10-85-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004.
Used to perfor Terminated |
DTQ | K060053 |
| Jan 26, 2011 | Sorin Group USA, Inc. Stockert, S5 Roller Pump 150, Part No.: 10-80-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004.
Used to perform, con Terminated |
DTQ | K060053 |
| Jan 7, 2011 | Terumo Cardiovascular Systems Corporation Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI.
The occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regula 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| Jul 22, 2010 | Sorin Group USA, Inc. B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5. Terminated |
DTQ | K092463 |
| Jul 22, 2010 | Sorin Group USA, Inc. Mast Roller Pump, Catalog 50-80-00, for use with Sorin HLM C5 and HLM S5. Terminated |
DTQ | K062396 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| Dec 10, 2008 | Terumo Cardiovascular Systems Corporation Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900. Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195240.
Le 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 | K022947 |
| 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 | K022947 |
| Nov 7, 2008 | Terumo Cardiovascular Systems Corporation Terumo Sarns Level Sensor II (red) (Part # 195274) alarm level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Sy Terminated |
DTQ | K871131 |
| Nov 7, 2008 | Terumo Cardiovascular Systems Corporation Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Terminated |
DTQ | K871131 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| 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 | K022947 |
| Jul 23, 2007 | Medtronic Perfusion Systems Medtronic Performer CPB-Universal R2100375.
Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Terminated |
DTQ | K052555 K070213 |
| Jul 7, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States). Terminated |
DTQ | None listed |
| Jul 7, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395. Terminated |
DTQ | K915183 K953904 |
| Jul 7, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407. Terminated |
DTQ | K915183 K953904 |
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