DWA — Control, Pump Speed, Cardiopulmonary Bypass Class II
FDA product code DWA covers "Control, Pump Speed, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4380. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |