OZT · Class II · 21 CFR 870.1255

FDA Product Code OZT: Balloon Aortic Valvuloplasty

A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.

Leading manufacturers include C.R. Bard, Inc., Dongguan TT Medical, Inc. and Toray Industries, Inc..

22
Total
21
Cleared
175d
Avg days
2012
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 147d recently vs 181d historically

FDA 510(k) Cleared Balloon Aortic Valvuloplasty Devices (Product Code OZT)

22 devices
1–22 of 22
Cleared May 06, 2026
KardiaPSI Balloon Catheter
K253855
Intervention Tech, Inc. ; dba Corvention
Cardiovascular · 154d
Cleared Mar 20, 2026
Valvuloplasty Balloon Catheter (ValvuloPro)
K260437
Dongguan TT Medical, Inc.
Cardiovascular · 37d
Cleared Mar 11, 2025
OutFlo Aortic Valve Dilatation Balloon Catheter
K241562
Disa Medinotec
Cardiovascular · 284d
Cleared Jul 31, 2024
ValvuloPro Valvuloplasty Balloon Catheter
K240967
Dongguan TT Medical, Inc.
Cardiovascular · 113d
Cleared Oct 12, 2023
ValvuloPro Valvuloplasty Balloon Catheter
K231814
Dongguan TT Medical, Inc.
Cardiovascular · 113d
Cleared Dec 18, 2022
INOUE BALLOON A
K220881
Toray Industries, Inc.
Cardiovascular · 268d
Cleared Dec 13, 2017
True Flow Valvuloplasty Perfusion Catheter
K172932
C.R. Bard, Inc.
Cardiovascular · 78d
Cleared Jan 19, 2016
True Flow Valvuloplasty Perfusion Catheter
K152613
C.R. Bard, Inc.
Cardiovascular · 127d
Cleared Jun 17, 2015
True Dilatation Balloon Valvuloplasty Catheter
K150667
C.R. Bard, Inc.
Cardiovascular · 93d
Cleared Apr 17, 2015
TRUE FLOW VALVULOPLASTY PERFUSION CATHETER
K142083
C.R. Bard, Inc.
Cardiovascular · 260d
Cleared Sep 18, 2014
TRUE BA V BALLOON VALVULOPLASTY CATHETER
K141985
C.R. Bard, Inc.
Cardiovascular · 58d

About Product Code OZT - Regulatory Context

510(k) Submission Activity

22 total 510(k) submissions under product code OZT since 2012, with 21 receiving FDA clearance (average review time: 175 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OZT Product Code

Recent submissions under OZT have taken an average of 147 days to reach a decision - down from 181 days historically, suggesting improved FDA processing for this classification.

OZT devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →