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

Suction Control, Intracardiac, Cardiopulmonary Bypass

21 CFR 870.4430 / Cardiovascular
FDA source (opens on fda.gov)

DWD is the FDA product code for Suction Control, Intracardiac, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4430. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DWD
Device name
Suction Control, Intracardiac, Cardiopulmonary Bypass
Regulation
21 CFR 870.4430
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
0

Clearances, product code DWD

By decision year
15 clearances under product code DWD with a decision year between 1976 and 2000, 1986 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DWD by decision year
YearClearances
19761
19832
19851
19863
19871
19901
19911
19923
19931
20001

Applicants with the most clearances

Product code DWD
Applicants holding the most 510(k) clearances under product code DWD
ApplicantClearances
American Omni Medical, Inc.3
BD Becton Dickinson Vacutainer Systems Preanalytic3
3M Health Care, Sarns1
Atrium Medical Corporation1
Baxter Bentley Laboratories, Inc.1
Delta Medical Industries1
DeRoyal Industries, Inc.1
Gish Biomedical, Inc.1
Instrumentation Laboratory Co.1
International Biophysics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code