OZT — Balloon Aortic Valvuloplasty Class II
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 |
|---|---|---|---|
| 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 |
| K122012 | numed | Z-MED Z-MED II | October 4, 2012 |
| DEN080015 | numed | NUCLEUS-X PTV CATHETER | June 11, 2012 |