FDA 510(k) Applications for Medical Device Product Code "DWA"
(Control, Pump Speed, Cardiopulmonary Bypass)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K200306 | Abbott (formerly Thoratec Corporation) | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit | 03/06/2020 |
| K230698 | AMPTD Inc. | Anivia SG1000 Pump Console | 04/18/2023 |
| K221491 | APMTD, Inc. | Anivia SG1000 Pump Console | 02/03/2023 |
| K971421 | C.R. BARD, INC. | BARD ISOFLOW BLOOD PUMP | 05/14/1998 |
| K061369 | CARDIAC ASSIST, INC. | TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 | 08/22/2006 |
| K102129 | LEVITRONIX LLC. | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | 08/27/2010 |
| K093832 | LEVITRONIX LLC. | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES | 01/13/2010 |
| K053630 | LEVITRONIX LLC. | LEVITRONIX CENTRIMAG PRIMARY CONSOLE | 01/26/2006 |
| K081221 | LEVITRONIX LLC. | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE | 06/19/2008 |
| K083340 | LEVITRONIX LLC. | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE | 11/26/2008 |
| K090004 | LEVITRONIX LLC. | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES | 01/15/2009 |
| K070286 | Medtronic | BIO-CONSOLE, MODEL 560 | 05/22/2007 |
| K131964 | MEDTRONIC INC. | BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE | 07/24/2013 |
| K080824 | MEDTRONIC PERFUSION SYSTEMS | BIO-CONSOLE 560 | 05/07/2008 |
| K051303 | MEDTRONIC PERFUSION SYSTEMS | BIO-CONSOLE, MODEL 560 | 06/10/2005 |
| K112225 | SORIN GROUP DEUTSCHLAND GMBH | SORIN CENTRIFUGAL PUMP 5 (CP5) | 09/20/2011 |
| K103468 | SORIN GROUP DEUTSCHLAND GMBH | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) | 01/20/2011 |
| K091008 | SORIN GROUP DEUTSCHLAND GMBH | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 | 07/15/2009 |
| K192838 | Spectrum Medical Ltd | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | 04/13/2020 |
| K011838 | STOCKERT INSTRUMENTE GMBH | CENTRIFUGAL PUMP | 02/05/2002 |
| K032213 | STOCKERT INSTRUMENTE GMBH | STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP | 08/29/2003 |
| K042374 | STOCKERT INSTRUMENTE GMBH | STOCKERT SCP RHYTHM | 09/23/2004 |
| K131179 | THORATEC CORP | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR | 07/18/2013 |
| K191557 | Thoratec Corporation (now part of Abbott) | CentriMag Acute Circulatory Support System | 07/10/2019 |
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