Product code DWA
- Device name
- Control, Pump Speed, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4380
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232788 | INSPIRA ART100 | Inspira Technologies Oxy B.H.N. , Ltd. | 2024-05-24 |
| K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023-04-18 |
| K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023-02-03 |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | Spectrum Medical , Ltd. | 2020-04-13 |
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit | Abbott (Formerly Thoratec Corporation) | 2020-03-06 |
| K191557 | CentriMag Acute Circulatory Support System | Thoratec Corporation (Now Part of Abbott) | 2019-07-10 |
| K131964 | BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE | Medtronic, Inc. | 2013-07-24 |
| K131179 | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR | Thoratec Corp | 2013-07-18 |
| K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) | Sorin Group Deutschland GmbH | 2011-09-20 |
| K103468 | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) | Sorin Group Deutschland GmbH | 2011-01-20 |
| K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | Levitronix, LLC | 2010-08-27 |
| K093832 | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES | Levitronix, LLC | 2010-01-13 |
| K091008 | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 | Sorin Group Deutschland GmbH | 2009-07-15 |
| K090004 | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES | Levitronix, LLC | 2009-01-15 |
| K083340 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE | Levitronix, LLC | 2008-11-26 |
| K081221 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE | Levitronix, LLC | 2008-06-19 |
| K080824 | BIO-CONSOLE 560 | Medtronic Perfusion Systems | 2008-05-07 |
| K070286 | BIO-CONSOLE, MODEL 560 | Medtronic | 2007-05-22 |
| K061369 | TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 | Cardiacassist, Inc. | 2006-08-22 |
| K053630 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE | Levitronix, LLC | 2006-01-26 |
| K051303 | BIO-CONSOLE, MODEL 560 | Medtronic Perfusion Systems | 2005-06-10 |
| K042374 | STOCKERT SCP RHYTHM | Stockert Instrumente GmbH | 2004-09-23 |
| K032213 | STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP | Stockert Instrumente GmbH | 2003-08-29 |
| K011838 | CENTRIFUGAL PUMP | Stockert Instrumente GmbH | 2002-02-05 |
| K971421 | BARD ISOFLOW BLOOD PUMP | C.R. Bard, Inc. | 1998-05-14 |
| K950739 | 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM | 3M Health Care, Sarns | 1995-11-17 |
| K936091 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER | Medtronic Bio-Medicus, Inc. | 1994-12-23 |
| K941921 | BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 | Medtronic Bio-Medicus, Inc. | 1994-07-20 |
| K926357 | MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 | Medtronic Bio-Medicus, Inc. | 1993-06-02 |
| K924206 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E | Medtronic Bio-Medicus, Inc. | 1993-05-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640135140153 | CentriMag™ | Thoratec Corporation | 2026-02-19 |
| 00850000067141 | Anivia SG1000 Pump Console | APMTD, Inc. | 2025-08-26 |
| 07290117830109 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 17290117830090 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 07290117830086 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 17290117830069 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 17290117830052 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 07290117830048 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 07290117830116 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 17290117830144 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 07290117830147 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 07290117830093 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 07290117830062 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 07290117830055 | INSPIRA ART100 | INSPIRA TECHNOLOGIES OXY B.H.N LTD | 2024-11-10 |
| 00850000067059 | Anivia SG1000 Pump Console | APMTD, Inc. | 2024-09-11 |
| 00850000067066 | Anivia SG1000 Pump Console | APMTD, Inc. | 2024-09-11 |
| 00850000067073 | Anivia SG1000 Pump Console | APMTD, Inc. | 2024-09-11 |
| 00850000067080 | Anivia SG1000 Pump Console | APMTD, Inc. | 2024-09-11 |
| 00850000067097 | Anivia SG1000 Pump Console | APMTD, Inc. | 2024-09-11 |
| 00850000067103 | Anivia SG1000 Pump Console | APMTD, Inc. | 2024-09-11 |
| 00850000067110 | Anivia SG1000 Pump Console | APMTD, Inc. | 2024-09-11 |
| 05415067036414 | CentriMag™ | Thoratec Corporation | 2023-05-17 |
| 10860001797968 | OXY-1 System | Breethe, Inc. | 2020-12-02 |
| 00814112020630 | LifeSPARC | CARDIACASSIST, INC. | 2020-05-27 |
| 00814112020623 | LifeSPARC | CARDIACASSIST, INC. | 2020-05-27 |
| 00886799001721 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000342 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000236 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000229 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |
| 00886799000212 | Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 2016-09-23 |