ClearanceBrief
Panels › Cardiovascular › Product code DWA · Class 2

Control, Pump Speed, Cardiopulmonary Bypass

Regulation 870.4380

0510(k)s in 12 months (37 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
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Top companies in DWA

Company510(k)sRecalls
Levitronix, LLC60
Medtronic Bio-Medicus, Inc.60
Sorin Group Deutschland GmbH33
Bio Medicus, Inc.30
LivaNova Deutschland GmbH03
Medtronic Perfusion Systems21
Stockert Instrumente GmbH30
Apmtd, Inc.20
Cardiac Assist, Inc02
Medtronic20
Decided510(k)Device and applicantCode
May 24, 2024K232788INSPIRA ART100
Inspira Technologies Oxy B.H.N. , Ltd., IL
DWA
Apr 18, 2023K230698Anivia SG1000 Pump Console
Apmtd, Inc.
DWA
Feb 3, 2023K221491Anivia SG1000 Pump Console
Apmtd, Inc.
DWA
Apr 13, 2020K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
Spectrum Medical , Ltd., GB
DWA
Mar 6, 2020K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
Abbott (Formerly Thoratec Corporation)
DWA
Jul 10, 2019K191557CentriMag Acute Circulatory Support System
Thoratec Corporation (Now Part of Abbott)
DWA
Jul 24, 2013K131964BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
Medtronic, Inc.
DWA
Jul 18, 2013K131179CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
Thoratec Corp
DWA
Sep 20, 2011K112225SORIN CENTRIFUGAL PUMP 5 (CP5)
Sorin Group Deutschland GmbH
DWA
Jan 20, 2011K103468STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
Sorin Group Deutschland GmbH
DWA
Aug 27, 2010K102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
Levitronix, LLC
DWA
Jan 13, 2010K093832LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
Levitronix, LLC
DWA
Jul 15, 2009K091008STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
Sorin Group Deutschland GmbH
DWA
Jan 15, 2009K090004LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
Levitronix, LLC
DWA
Nov 26, 2008K083340LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE
Levitronix, LLC
DWA
Jun 19, 2008K081221LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
Levitronix, LLC
DWA
May 7, 2008K080824BIO-CONSOLE 560
Medtronic Perfusion Systems
DWA
May 22, 2007K070286BIO-CONSOLE, MODEL 560
Medtronic
DWA
Aug 22, 2006K061369TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
Cardiacassist, Inc.
DWA
Jan 26, 2006K053630LEVITRONIX CENTRIMAG PRIMARY CONSOLE
Levitronix, LLC
DWA
Jun 10, 2005K051303BIO-CONSOLE, MODEL 560
Medtronic Perfusion Systems
DWA
Sep 23, 2004K042374STOCKERT SCP RHYTHM
Stockert Instrumente GmbH
DWA
Aug 29, 2003K032213STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Stockert Instrumente GmbH
DWA
Feb 5, 2002K011838CENTRIFUGAL PUMP
Stockert Instrumente GmbH
DWA
May 14, 1998K971421BARD ISOFLOW BLOOD PUMP
C.R. Bard, Inc.
DWA
Nov 17, 1995K9507393M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
3M Health Care, Sarns
DWA
Dec 23, 1994K936091MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER
Medtronic Bio-Medicus, Inc.
DWA
Jul 20, 1994K941921BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550
Medtronic Bio-Medicus, Inc.
DWA
Jun 2, 1993K926357MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150
Medtronic Bio-Medicus, Inc.
DWA
May 7, 1993K924206MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E
Medtronic Bio-Medicus, Inc.
DWA
May 6, 1993K924205MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550
Medtronic Bio-Medicus, Inc.
DWA
May 20, 1992K914754MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D
Medtronic Bio-Medicus, Inc.
DWA
Jun 28, 1990K901584BIO-MEDICUS BIO CONSOLE MODELS 540 A B C
Bio Medicus, Inc.
DWA
Jan 8, 1986K854133BIO MEDICUS BIO CONSOLE 540
Bio Medicus, Inc.
DWA
Oct 11, 1985K853126BIO PACK MODEL 200
Bio Medicus, Inc.
DWA
Aug 10, 1984K842503GAMBRO PULSATILE MONITOR PLM 10-200
Gambro, Inc.
DWA
Aug 31, 1978K780952MODEL 1812 CONTROL CONSOLE, ACCESSORIEX
Medtronic Vascular
DWA

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