FDA Product Code
FDA Product Code DWA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4380
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232788 | INSPIRA ART100 | Inspira Technologies Oxy B.H.N. , Ltd. | 2024-05-24 | Traditional | PDF ↗ |
| K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023-04-18 | Special | PDF ↗ |
| K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023-02-03 | Traditional | PDF ↗ |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | Spectrum Medical , Ltd. | 2020-04-13 | Traditional | PDF ↗ |
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit | Abbott (Formerly Thoratec Corporation) | 2020-03-06 | Special | PDF ↗ |
| K191557 | CentriMag Acute Circulatory Support System | Thoratec Corporation (Now Part of Abbott) | 2019-07-10 | Special | PDF ↗ |
| K131964 | BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE | Medtronic, Inc. | 2013-07-24 | Special | PDF ↗ |
| K131179 | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR | Thoratec Corp | 2013-07-18 | Special | PDF ↗ |
| K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) | Sorin Group Deutschland GmbH | 2011-09-20 | Special | PDF ↗ |
| K103468 | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) | Sorin Group Deutschland GmbH | 2011-01-20 | Traditional | PDF ↗ |
| K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | Levitronix, LLC | 2010-08-27 | Special | PDF ↗ |
| K093832 | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES | Levitronix, LLC | 2010-01-13 | Special | PDF ↗ |
| K091008 | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 | Sorin Group Deutschland GmbH | 2009-07-15 | Special | PDF ↗ |
| K090004 | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES | Levitronix, LLC | 2009-01-15 | Special | PDF ↗ |
| K083340 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE | Levitronix, LLC | 2008-11-26 | Special | PDF ↗ |
| K081221 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE | Levitronix, LLC | 2008-06-19 | Traditional | PDF ↗ |
| K080824 | BIO-CONSOLE 560 | Medtronic Perfusion Systems | 2008-05-07 | Traditional | PDF ↗ |
| K070286 | BIO-CONSOLE, MODEL 560 | Medtronic | 2007-05-22 | Traditional | PDF ↗ |
| K061369 | TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 | Cardiacassist, Inc. | 2006-08-22 | Special | PDF ↗ |
| K053630 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE | Levitronix, LLC | 2006-01-26 | Special | PDF ↗ |
| K051303 | BIO-CONSOLE, MODEL 560 | Medtronic Perfusion Systems | 2005-06-10 | Special | PDF ↗ |
| K042374 | STOCKERT SCP RHYTHM | Stockert Instrumente GmbH | 2004-09-23 | Special | PDF ↗ |
| K032213 | STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP | Stockert Instrumente GmbH | 2003-08-29 | Traditional | PDF ↗ |
| K011838 | CENTRIFUGAL PUMP | Stockert Instrumente GmbH | 2002-02-05 | Traditional | PDF ↗ |
| K971421 | BARD ISOFLOW BLOOD PUMP | C.R. Bard, Inc. | 1998-05-14 | Traditional | PDF ↗ |
| K950739 | 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM | 3M Health Care, Sarns | 1995-11-17 | Traditional | PDF ↗ |
| K936091 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER | Medtronic Bio-Medicus, Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K941921 | BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 | Medtronic Bio-Medicus, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K926357 | MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 | Medtronic Bio-Medicus, Inc. | 1993-06-02 | Traditional | PDF ↗ |
| K924206 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E | Medtronic Bio-Medicus, Inc. | 1993-05-07 | Traditional | PDF ↗ |
| K924205 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 | Medtronic Bio-Medicus, Inc. | 1993-05-06 | Traditional | PDF ↗ |
| K914754 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D | Medtronic Bio-Medicus, Inc. | 1992-05-20 | Traditional | PDF ↗ |
| K901584 | BIO-MEDICUS BIO CONSOLE MODELS 540 A B C | Bio Medicus, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K854133 | BIO MEDICUS BIO CONSOLE 540 | Bio Medicus, Inc. | 1986-01-08 | Traditional | PDF ↗ |
| K853126 | BIO PACK MODEL 200 | Bio Medicus, Inc. | 1985-10-11 | Traditional | PDF ↗ |
| K842503 | GAMBRO PULSATILE MONITOR PLM 10-200 | Gambro, Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K780952 | MODEL 1812 CONTROL CONSOLE, ACCESSORIEX | Medtronic Vascular | 1978-08-31 | Traditional | PDF ↗ |
Product code DWA · Class II · Cardiovascular. Data: openFDA.