| KardiaPSI Balloon Catheter (K253855) | Intervention Tech, Inc. ; dba Corvention | 2026-05-06 |
| Valvuloplasty Balloon Catheter (ValvuloPro) (K260437) | Dongguan TT Medical, Inc. | 2026-03-20 |
| OutFlo Aortic Valve Dilatation Balloon Catheter (K241562) | Disa Medinotec | 2025-03-11 |
| ValvuloPro Valvuloplasty Balloon Catheter (K240967) | Dongguan TT Medical, Inc. | 2024-07-31 |
| ValvuloPro Valvuloplasty Balloon Catheter (K231814) | Dongguan TT Medical, Inc. | 2023-10-12 |
| INOUE BALLOON A (K220881) | Toray Industries, Inc. | 2022-12-18 |
| True Flow Valvuloplasty Perfusion Catheter (K172932) | C.R. Bard, Inc. | 2017-12-13 |
| True Flow Valvuloplasty Perfusion Catheter (K152613) | C.R. Bard, Inc. | 2016-01-19 |
| V8 Balloon Aortic Valvuloplasty Catheter (K152150) | Intervalve, Inc. | 2015-12-18 |
| True Dilatation Balloon Valvuloplasty Catheter (K150667) | C.R. Bard, Inc. | 2015-06-17 |
| TRUE FLOW VALVULOPLASTY PERFUSION CATHETER (K142083) | C.R. Bard, Inc. | 2015-04-17 |
| V8 Transluminal BAV Catheter (K150343) | Intervalve, Inc. | 2015-04-03 |
| Ascendra Balloon Aortic Valvaloplasty Catheter (K142199) | Edwards Lifesciences | 2014-10-29 |
| TRUE BA V BALLOON VALVULOPLASTY CATHETER (K141985) | C.R. Bard, Inc. | 2014-09-18 |
| EDWARDS TRANSFEMORAL BALLOON CATHETER (K140241) | Edwards Lifesciences, LLC | 2014-07-03 |
| V8 TRANSLUMINAL BAV CATHETER (K133607) | Intervalve, Inc. | 2014-02-11 |
| TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM (K133569) | Bard Peripheral Vascular, Inc. | 2013-12-20 |
| V8 TRANSLUMINAL BAV CATHETER (K132728) | Intervalve, Inc. | 2013-11-22 |
| V8 TRANSLUMINAL BAV CATHETER (K123111) | Intervalve, Inc. | 2013-01-31 |
| TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA (K121083) | Loma Vista Medical | 2012-10-11 |
| Z-MED Z-MED II (K122012) | NuMED, Inc. | 2012-10-04 |
| NUCLEUS-X PTV CATHETER (DEN080015) | NuMED, Inc. | 2012-06-11 |