DWA · Control, Pump Speed, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4380 · Class 2
Overview
| Product Code | DWA |
|---|---|
| Device Name | Control, Pump Speed, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4380 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232788 | INSPIRA ART100 | Inspira Technologies Oxy B.H.N. , Ltd. | May 24, 2024 | SESE |
| K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | Apr 18, 2023 | SESE |
| K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | Feb 3, 2023 | SESE |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | Spectrum Medical , Ltd. | Apr 13, 2020 | SESE |
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit | Abbott (Formerly Thoratec Corporation) | Mar 6, 2020 | SESE |
| K191557 | CentriMag Acute Circulatory Support System | Thoratec Corporation (Now Part of Abbott) | Jul 10, 2019 | SESE |
| K131964 | BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE | Medtronic, Inc. | Jul 24, 2013 | SESE |
| K131179 | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR | Thoratec Corp | Jul 18, 2013 | SESE |
| K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) | Sorin Group Deutschland GmbH | Sep 20, 2011 | SESE |
| K103468 | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) | Sorin Group Deutschland GmbH | Jan 20, 2011 | SESE |
| K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | Levitronix, LLC | Aug 27, 2010 | SESE |
| K093832 | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES | Levitronix, LLC | Jan 13, 2010 | SESE |
| K091008 | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 | Sorin Group Deutschland GmbH | Jul 15, 2009 | SESE |
| K090004 | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES | Levitronix, LLC | Jan 15, 2009 | SESE |
| K083340 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE | Levitronix, LLC | Nov 26, 2008 | SESE |
| K081221 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE | Levitronix, LLC | Jun 19, 2008 | SESE |
| K080824 | BIO-CONSOLE 560 | Medtronic Perfusion Systems | May 7, 2008 | SESE |
| K070286 | BIO-CONSOLE, MODEL 560 | Medtronic | May 22, 2007 | SESE |
| K061369 | TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 | Cardiacassist, Inc. | Aug 22, 2006 | SESE |
| K053630 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE | Levitronix, LLC | Jan 26, 2006 | SESE |
Top Applicants
- Medtronic Bio-Medicus, Inc. — 6 clearances
- Levitronix, LLC — 6 clearances
- Stockert Instrumente GmbH — 3 clearances
- Sorin Group Deutschland GmbH — 3 clearances
- Bio Medicus, Inc. — 3 clearances
