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) | Mar 20, 2026 |
| K241562 | Disa Medinotec | OutFlo Aortic Valve Dilatation Balloon Catheter | Mar 11, 2025 |
| K240967 | Dongguan Tt Medical | ValvuloPro Valvuloplasty Balloon Catheter | Jul 31, 2024 |
| K231814 | Dongguan Tt Medical | ValvuloPro Valvuloplasty Balloon Catheter | Oct 12, 2023 |
| K220881 | Toray Industries | INOUE BALLOON A | Dec 18, 2022 |
| K172932 | C.R. Bard | True Flow Valvuloplasty Perfusion Catheter | Dec 13, 2017 |
| K152613 | C.R. Bard | True Flow Valvuloplasty Perfusion Catheter | Jan 19, 2016 |
| K152150 | Intervalve | V8 Balloon Aortic Valvuloplasty Catheter | Dec 18, 2015 |
| K150667 | C.R. Bard | True Dilatation Balloon Valvuloplasty Catheter | Jun 17, 2015 |
| K142083 | C.R. Bard | TRUE FLOW VALVULOPLASTY PERFUSION CATHETER | Apr 17, 2015 |
| K150343 | Intervalve | V8 Transluminal BAV Catheter | Apr 3, 2015 |
| K142199 | Edwards Lifesciences | Ascendra Balloon Aortic Valvaloplasty Catheter | Oct 29, 2014 |
| K141985 | C.R. Bard | TRUE BA V BALLOON VALVULOPLASTY CATHETER | Sep 18, 2014 |
| K140241 | Edwards Lifesciences | EDWARDS TRANSFEMORAL BALLOON CATHETER | Jul 3, 2014 |
| K133607 | Intervalve | V8 TRANSLUMINAL BAV CATHETER | Feb 11, 2014 |
| K133569 | Bard Peripheral Vascular | TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 | Dec 20, 2013 |
| K132728 | Intervalve | V8 TRANSLUMINAL BAV CATHETER | Nov 22, 2013 |
| K123111 | Intervalve | V8 TRANSLUMINAL BAV CATHETER | Jan 31, 2013 |
| K121083 | Loma Vista Medical | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, | Oct 11, 2012 |