DWA · Class II · 21 CFR 870.4380

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

Leading manufacturers include Apmtd, Inc., Inspira Technologies Oxy B.H.N. , Ltd. and Medtronic Vascular.

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 May 14, 1998
BARD ISOFLOW BLOOD PUMP
K971421
C.R. Bard, Inc.
Cardiovascular · 393d
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.