Balloon Aortic Valvuloplasty
FDA product code OZT · Class II (moderate risk) · 21 CFR 870.1255 · Cardiovascular
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
21510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253855 | KardiaPSI Balloon CatheterOZT · Traditional | Intervention Tech, Inc. ; dba Corvention | 05/06/2026SE |
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro)OZT · Special | Dongguan TT Medical, Inc. | 03/20/2026SE |
| K241562 | OutFlo Aortic Valve Dilatation Balloon CatheterOZT · Traditional | Disa Medinotec | 03/11/2025SE |
| K240967 | ValvuloPro Valvuloplasty Balloon CatheterOZT · Special | Dongguan TT Medical, Inc. | 07/31/2024SE |
| K231814 | ValvuloPro Valvuloplasty Balloon CatheterOZT · Traditional | Dongguan TT Medical, Inc. | 10/12/2023SE |
| K220881 | Inoue Balloon aOZT · Traditional | Toray Industries, Inc. | 12/18/2022SE |
| K172932 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | C.R. Bard, Inc. | 12/13/2017SE |
| K152613 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | C.R. Bard, Inc. | 01/19/2016SE |
| K152150 | V8 Balloon Aortic Valvuloplasty CatheterOZT · Traditional | Intervalve, Inc. | 12/18/2015SE |
| K150667 | True Dilatation Balloon Valvuloplasty CatheterOZT · Traditional | C.R. Bard, Inc. | 06/17/2015SE |
| K142083 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | C.R. Bard, Inc. | 04/17/2015SE |
| K150343 | V8 Transluminal BAV CatheterOZT · Special | Intervalve, Inc. | 04/03/2015SE |
| K142199 | Ascendra Balloon Aortic Valvaloplasty CatheterOZT · Traditional | Edwards Lifesciences | 10/29/2014SE |
| K141985 | True Ba V Balloon Valvuloplasty CatheterOZT · Traditional | C.R. Bard, Inc. | 09/18/2014SE |
| K140241 | Edwards Transfemoral Balloon CatheterOZT · Traditional | Edwards Lifesciences, LLC | 07/03/2014SE |
| K133607 | V8 Transluminal Bav CatheterOZT · Traditional | Intervalve, Inc. | 02/11/2014SE |
| K133569 | True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X…OZT · Special | Bard Peripheral Vascular, Inc. | 12/20/2013SE |
| K132728 | V8 Transluminal Bav CatheterOZT · Special | Intervalve, Inc. | 11/22/2013SE |
| K123111 | V8 Transluminal Bav CatheterOZT · Traditional | Intervalve, Inc. | 01/31/2013SE |
| K121083 | True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True…OZT · Traditional | Loma Vista Medical | 10/11/2012SE |
| K122012 | Z-Med Z-Med IIOZT · Traditional | NuMED, Inc. | 10/04/2012SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1621-2014 Class II | InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110…Leak issues were discovered through accelerated age testing. | InterValve Inc | 03/14/2014Terminated |
| Z-1566-2013 Class II | TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12…Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon… | Loma Vista Medical | 03/18/2013Terminated |