DWA · Class II · 21 CFR 870.4380

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

Leading manufacturers include Sorin Group Deutschland GmbH, Apmtd, Inc. and Medtronic Perfusion Systems.

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 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 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 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 May 14, 1998
BARD ISOFLOW BLOOD PUMP
K971421
C.R. Bard, Inc.
Cardiovascular · 393d
Cleared Nov 17, 1995
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
K950739
3M Health Care, Sarns
Cardiovascular · 273d
Cleared Aug 10, 1984
GAMBRO PULSATILE MONITOR PLM 10-200
K842503
Gambro, Inc.
Cardiovascular · 45d
Cleared Aug 31, 1978
MODEL 1812 CONTROL CONSOLE, ACCESSORIEX
K780952
Medtronic Vascular
Cardiovascular · 83d

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.