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

Valvulotome

21 CFR 870.4885 / Cardiovascular
FDA source (opens on fda.gov)

MGZ is the FDA product code for Valvulotome, a class II device type, regulated under 21 CFR 870.4885. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
MGZ
Device name
Valvulotome
Regulation
21 CFR 870.4885
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
27
Ingested recalls
6

Clearances, product code MGZ

By decision year
27 clearances under product code MGZ with a decision year between 1991 and 2026, 1991 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code MGZ by decision year
YearClearances
19914
19923
19934
19941
19951
19971
19991
20011
20041
20081
20111
20132
20142
20191
20221
20251
20261

Applicants with the most clearances

Product code MGZ
Applicants holding the most 510(k) clearances under product code MGZ
ApplicantClearances
LeMaitre Vascular Inc.6
Vascutech, Inc.4
Cardio Source2
Intramed Laboratories, Inc.2
LimFlow Inc.2
Aveera Medical1
Baxter Edwards1
Edwards Lifesciences LLC1
Endovascular, Inc.1
Geister Medizin Technik GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code