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

Replacement Heart-Valve

21 CFR 870.3925 / Cardiovascular
FDA source (opens on fda.gov)

DYE is the FDA product code for Replacement Heart-Valve, a class III device type, regulated under 21 CFR 870.3925. FDA's definition for this code reads: "Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))". As of , FDA records hold no 510(k) clearances under this code and 8 recalls.

Classification record

Product code
DYE
Device name
Replacement Heart-Valve
FDA definition
Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Regulation
21 CFR 870.3925
Device class
Class III
Review panel
Cardiovascular
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
8

Companies listing this code with FDA

Companies whose registered establishments list this code