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

Sizer, Heart-Valve, Prosthesis

21 CFR 870.3945 / Cardiovascular
FDA source (opens on fda.gov)

DTI is the FDA product code for Sizer, Heart-Valve, Prosthesis, a class I device type, regulated under 21 CFR 870.3945. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
DTI
Device name
Sizer, Heart-Valve, Prosthesis
Regulation
21 CFR 870.3945
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
7
Ingested recalls
2

Clearances, product code DTI

By decision year
7 clearances under product code DTI with a decision year between 1980 and 1995, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DTI by decision year
YearClearances
19801
19821
19852
19881
19931
19951

Applicants with the most clearances

Product code DTI
Applicants holding the most 510(k) clearances under product code DTI
ApplicantClearances
Carbomedics, Inc.2
Baxter Healthcare Corporation1
Celtech1
Hancock Laboratories, Inc.1
Hemex Scientific, Inc.1
Medtronic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order