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

Defoamer, Cardiopulmonary Bypass

21 CFR 870.4230 / Cardiovascular
FDA source (opens on fda.gov)

DTP is the FDA product code for Defoamer, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4230. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DTP
Device name
Defoamer, Cardiopulmonary Bypass
Regulation
21 CFR 870.4230
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
34
Ingested recalls
0

Clearances, product code DTP

By decision year
34 clearances under product code DTP with a decision year between 1980 and 2010, 1983 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DTP by decision year
YearClearances
19802
19822
19833
19843
19853
19863
19872
19881
19903
19913
19931
19941
19961
19992
20001
20011
20081
20101

Applicants with the most clearances

Product code DTP
Applicants holding the most 510(k) clearances under product code DTP
ApplicantClearances
Medtronic, Inc.4
Scimed Life Systems, Inc.4
Shiley, Inc.4
C.R. Bard Inc3
Gish Biomedical, Inc.3
3M Health Care, Sarns2
American Bentley2
LivaNova USA, Inc.2
3M Company1
Cardio Metrics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code