OZT — Balloon Aortic Valvuloplasty Class II
FDA product code OZT covers "Balloon Aortic Valvuloplasty", a Class II medical device regulated under 21 CFR 870.1255. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OZT
- Device Class
- Class II
- Regulation Number
- 870.1255
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253855 | intervention tech, inc. ; dba corvention | KardiaPSI Balloon Catheter | May 6, 2026 |
| K260437 | dongguan tt medical | Valvuloplasty Balloon Catheter (ValvuloPro) | March 20, 2026 |
| K241562 | disa medinotec | OutFlo Aortic Valve Dilatation Balloon Catheter | March 11, 2025 |
| K240967 | dongguan tt medical | ValvuloPro Valvuloplasty Balloon Catheter | July 31, 2024 |
| K231814 | dongguan tt medical | ValvuloPro Valvuloplasty Balloon Catheter | October 12, 2023 |
| K220881 | toray industries | INOUE BALLOON A | December 18, 2022 |
| K172932 | c.r. bard | True Flow Valvuloplasty Perfusion Catheter | December 13, 2017 |
| K152613 | c.r. bard | True Flow Valvuloplasty Perfusion Catheter | January 19, 2016 |
| K152150 | intervalve | V8 Balloon Aortic Valvuloplasty Catheter | December 18, 2015 |
| K150667 | c.r. bard | True Dilatation Balloon Valvuloplasty Catheter | June 17, 2015 |
| K142083 | c.r. bard | TRUE FLOW VALVULOPLASTY PERFUSION CATHETER | April 17, 2015 |
| K150343 | intervalve | V8 Transluminal BAV Catheter | April 3, 2015 |
| K142199 | edwards lifesciences | Ascendra Balloon Aortic Valvaloplasty Catheter | October 29, 2014 |
| K141985 | c.r. bard | TRUE BA V BALLOON VALVULOPLASTY CATHETER | September 18, 2014 |
| K140241 | edwards lifesciences | EDWARDS TRANSFEMORAL BALLOON CATHETER | July 3, 2014 |
| K133607 | intervalve | V8 TRANSLUMINAL BAV CATHETER | February 11, 2014 |
| K133569 | bard peripheral vascular | TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 | December 20, 2013 |
| K132728 | intervalve | V8 TRANSLUMINAL BAV CATHETER | November 22, 2013 |
| K123111 | intervalve | V8 TRANSLUMINAL BAV CATHETER | January 31, 2013 |
| K121083 | loma vista medical | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, | October 11, 2012 |