510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DWAClass II

Control, Pump Speed, Cardiopulmonary Bypass

21 CFR 870.4380 / Cardiovascular
FDA source (opens on fda.gov)

DWA is the FDA product code for Control, Pump Speed, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4380. As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
DWA
Device name
Control, Pump Speed, Cardiopulmonary Bypass
Regulation
21 CFR 870.4380
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
37
Ingested recalls
12

Clearances, product code DWA

By decision year
37 clearances under product code DWA with a decision year between 1978 and 2024, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DWA by decision year
YearClearances
19781
19841
19851
19861
19901
19921
19933
19942
19951
19981
20021
20031
20041
20051
20062
20071
20083
20092
20102
20112
20132
20191
20202
20232
20241

Applicants with the most clearances

Product code DWA
Applicants holding the most 510(k) clearances under product code DWA
ApplicantClearances
Levitronix, LLC6
Medtronic Bio-Medicus, Inc.6
Bio Medicus, Inc.3
Medtronic, Inc.3
LivaNova Deutschland GmbH3
Stockert Instrumente GmbH3
Apmtd, Inc.2
Medtronic Perfusion Systems2
3M Health Care, Sarns1
Abbott (Formerly Thoratec Corporation)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order