DWA — Control, Pump Speed, Cardiopulmonary Bypass Class II
FDA Device Classification
Classification Details
- Product Code
- DWA
- Device Class
- Class II
- Regulation Number
- 870.4380
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K232788 | inspira technologies oxy b.h.n. | INSPIRA ART100 | May 24, 2024 |
| K230698 | apmtd | Anivia SG1000 Pump Console | April 18, 2023 |
| K221491 | apmtd | Anivia SG1000 Pump Console | February 3, 2023 |
| K192838 | spectrum medical | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pre | April 13, 2020 |
| K200306 | abbott (formerly thoratec corporation) | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, C | March 6, 2020 |
| K191557 | thoratec corporation (now part of abbott) | CentriMag Acute Circulatory Support System | July 10, 2019 |
| K131964 | medtronic | BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE | July 24, 2013 |
| K131179 | thoratec | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR | July 18, 2013 |
| K112225 | sorin group deutschland | SORIN CENTRIFUGAL PUMP 5 (CP5) | September 20, 2011 |
| K103468 | sorin group deutschland | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) | January 20, 2011 |
| K102129 | levitronix | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | August 27, 2010 |
| K093832 | levitronix | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES | January 13, 2010 |
| K091008 | sorin group deutschland | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 | July 15, 2009 |
| K090004 | levitronix | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES | January 15, 2009 |
| K083340 | levitronix | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE | November 26, 2008 |
| K081221 | levitronix | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE | June 19, 2008 |
| K080824 | medtronic perfusion systems | BIO-CONSOLE 560 | May 7, 2008 |
| K070286 | medtronic | BIO-CONSOLE, MODEL 560 | May 22, 2007 |
| K061369 | cardiacassist | TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 | August 22, 2006 |
| K053630 | levitronix | LEVITRONIX CENTRIMAG PRIMARY CONSOLE | January 26, 2006 |