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

Rotator, Prosthetic Heart Valve

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

MOP is the FDA product code for Rotator, Prosthetic Heart Valve, a class I device type, regulated under 21 CFR 870.3935. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MOP
Device name
Rotator, Prosthetic Heart Valve
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
4
Ingested recalls
0

Clearances, product code MOP

By decision year
4 clearances under product code MOP with a decision year between 1995 and 1998, 1998 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MOP by decision year
YearClearances
19951
19961
19982

Applicants with the most clearances

Product code MOP
Applicants holding the most 510(k) clearances under product code MOP
ApplicantClearances
Carbomedics, Inc.2
Genzyme Surgical Product (Genzyme Biosurgery)1
Sulzer Carbomedics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MOP.