OZT

Balloon Aortic Valvuloplasty

Product code

OZT

Device name

Balloon Aortic Valvuloplasty

Device class

Class 2

21 CFR

21 CFR 870.1255

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

5

Summaries archived here

4 (direct download)

510(k) clearances (all years, FDA)

22 (all years; only the last 3 years are listed here)

FDA classification definition

A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-05-06.

4 summaries are archived here for direct download.