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

Balloon Aortic Valvuloplasty

21 CFR 870.1255 / Cardiovascular
FDA source (opens on fda.gov)

OZT is the FDA product code for Balloon Aortic Valvuloplasty, a class II device type, regulated under 21 CFR 870.1255. FDA's definition for this code reads: "A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve". As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
OZT
Device name
Balloon Aortic Valvuloplasty
FDA definition
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Regulation
21 CFR 870.1255
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
No
Ingested clearances
22
Ingested recalls
2

Clearances, product code OZT

By decision year
22 clearances under product code OZT with a decision year between 2012 and 2026, 2014 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code OZT by decision year
YearClearances
20123
20133
20144
20154
20161
20171
20221
20231
20241
20251
20262

Applicants with the most clearances

Product code OZT
Applicants holding the most 510(k) clearances under product code OZT
ApplicantClearances
C.R. Bard Inc5
Intervalve, Inc.5
Dongguan TT Medical, Inc.3
Edwards Lifesciences LLC2
Numed Inc2
Bard Peripheral Vascular Inc1
Disa Medinotec (Pty) Ltd1
Intervention Tech, Inc.; dba Corvention1
Loma Vista Medical1
Toray Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order