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

Tubing, Pump, Cardiopulmonary Bypass

21 CFR 870.4390 / Cardiovascular
FDA source (opens on fda.gov)

DWE is the FDA product code for Tubing, Pump, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4390. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and 48 recalls.

Classification record

Product code
DWE
Device name
Tubing, Pump, Cardiopulmonary Bypass
Regulation
21 CFR 870.4390
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
21
Ingested recalls
48

Clearances, product code DWE

By decision year
21 clearances under product code DWE with a decision year between 1980 and 2024, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DWE by decision year
YearClearances
19802
19812
19842
19891
19901
19911
19931
19981
19991
20001
20022
20051
20081
20091
20141
20151
20241

Applicants with the most clearances

Product code DWE
Applicants holding the most 510(k) clearances under product code DWE
ApplicantClearances
Terumo Cardiovascular Systems Corporation3
3M Health Care, Sarns2
LivaNova USA, Inc.2
MAQUET CARDIOPULMONARY GmbH2
Boston Scientific Corporation1
Cardio-Med-Associates, Inc.1
Electromedics, Inc.1
Enhanced Perfusion Systems, Inc.1
Extracorporeal Medical Specialities, Inc.1
Medrad, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order