| 2026-03-20 |
K260437 |
Valvuloplasty Balloon Catheter (ValvuloPro) |
OZT |
Class II |
Cardiovascular |
| 2024-07-31 |
K240967 |
ValvuloPro Valvuloplasty Balloon Catheter |
OZT |
Class II |
Cardiovascular |
| 2023-10-12 |
K231814 |
ValvuloPro Valvuloplasty Balloon Catheter |
OZT |
Class II |
Cardiovascular |
| 2023-06-29 |
K230374 |
Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) |
LOX |
— |
— |
| 2023-03-09 |
K222663 |
MultiStage Balloon Dilatation Catheter |
FGE |
Class II |
Gastroenterology, Urology |
| 2023-03-01 |
K222187 |
Multistage Balloon Dilatation Catheter |
KTI |
Class II |
Ear, Nose, Throat |