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

Holder, Heart-Valve, Prosthesis

21 CFR 870.3935 / Cardiovascular
FDA source (opens on fda.gov)

DTJ is the FDA product code for Holder, Heart-Valve, Prosthesis, a class I device type, regulated under 21 CFR 870.3935. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DTJ
Device name
Holder, Heart-Valve, Prosthesis
Regulation
21 CFR 870.3935
Device class
Class I
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
12
Ingested recalls
1

Clearances, product code DTJ

By decision year
12 clearances under product code DTJ with a decision year between 1979 and 1996, 1981 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DTJ by decision year
YearClearances
19792
19813
19861
19871
19881
19941
19951
19962

Applicants with the most clearances

Product code DTJ
Applicants holding the most 510(k) clearances under product code DTJ
ApplicantClearances
Carbomedics, Inc.3
Edwards Laboratories2
Shiley, Inc.2
Vascor, Inc.2
American Edwards Laboratories1
Baxter Edwards1
Baxter Healthcare Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code