DWA · Class II · 21 CFR 870.4380

FDA Product Code DWA: Control, Pump Speed, Cardiopulmonary Bypass

Leading manufacturers include Medtronic Bio-Medicus, Inc., Levitronix, LLC and Sorin Group Deutschland GmbH.

37
Total
37
Cleared
115d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Control, Pump Speed, Cardiopulmonary Bypass Devices (Product Code DWA)

37 devices
1–24 of 37
Cleared May 24, 2024
INSPIRA ART100
K232788
Inspira Technologies Oxy B.H.N. , Ltd.
Cardiovascular · 256d
Cleared Apr 18, 2023
Anivia SG1000 Pump Console
K230698
Apmtd, Inc.
Cardiovascular · 36d
Cleared Feb 03, 2023
Anivia SG1000 Pump Console
K221491
Apmtd, Inc.
Cardiovascular · 256d
Cleared Apr 13, 2020
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
K192838
Spectrum Medical , Ltd.
Cardiovascular · 193d
Cleared Mar 06, 2020
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
K200306
Abbott (Formerly Thoratec Corporation)
Cardiovascular · 29d
Cleared Jul 10, 2019
CentriMag Acute Circulatory Support System
K191557
Thoratec Corporation (Now Part of Abbott)
Cardiovascular · 28d
Cleared Jul 24, 2013
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
K131964
Medtronic, Inc.
Cardiovascular · 27d
Cleared Jul 18, 2013
CENTRIMAG PRIMARY CONSOLE (2ND GENERATION)
K131179
Thoratec Corp
Cardiovascular · 84d
Cleared Sep 20, 2011
SORIN CENTRIFUGAL PUMP 5 (CP5)
K112225
Sorin Group Deutschland GmbH
Cardiovascular · 48d
Cleared Jan 20, 2011
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
K103468
Sorin Group Deutschland GmbH
Cardiovascular · 57d
Cleared Aug 27, 2010
LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
K102129
Levitronix, LLC
Cardiovascular · 29d
Cleared Jan 13, 2010
LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
K093832
Levitronix, LLC
Cardiovascular · 30d
Cleared Jul 15, 2009
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
K091008
Sorin Group Deutschland GmbH
Cardiovascular · 97d
Cleared Jan 15, 2009
LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
K090004
Levitronix, LLC
Cardiovascular · 13d
Cleared Nov 26, 2008
LEVITRONIX CENTRIMAG PRIMARY CONSOLE
K083340
Levitronix, LLC
Cardiovascular · 14d
Cleared Jun 19, 2008
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
K081221
Levitronix, LLC
Cardiovascular · 50d
Cleared May 07, 2008
BIO-CONSOLE 560
K080824
Medtronic Perfusion Systems
Cardiovascular · 44d
Cleared May 22, 2007
BIO-CONSOLE, MODEL 560
K070286
Medtronic
Cardiovascular · 113d
Cleared Aug 22, 2006
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
K061369
Cardiacassist, Inc.
Cardiovascular · 97d
Cleared Jan 26, 2006
LEVITRONIX CENTRIMAG PRIMARY CONSOLE
K053630
Levitronix, LLC
Cardiovascular · 28d
Cleared Jun 10, 2005
BIO-CONSOLE, MODEL 560
K051303
Medtronic Perfusion Systems
Cardiovascular · 22d
Cleared Sep 23, 2004
STOCKERT SCP RHYTHM
K042374
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared Aug 29, 2003
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
K032213
Stockert Instrumente GmbH
Cardiovascular · 39d
Cleared Feb 05, 2002
CENTRIFUGAL PUMP
K011838
Stockert Instrumente GmbH
Cardiovascular · 238d

About Product Code DWA - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code DWA since 1978, with 37 receiving FDA clearance (average review time: 115 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.