FDA Product Code OZT: Balloon Aortic Valvuloplasty
A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.
Leading manufacturers include Dongguan TT Medical, Inc. and Disa Medinotec.
FDA 510(k) Cleared Balloon Aortic Valvuloplasty Devices (Product Code OZT)
About Product Code OZT - Regulatory Context
510(k) Submission Activity
21 total 510(k) submissions under product code OZT since 2012, with 20 receiving FDA clearance (average review time: 176 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OZT have taken an average of 145 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 →