| Device Type ID | 1021 |
| Device Name | Catheter, Percutaneous (valvuloplasty) |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MAD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1021 |
| Device | Catheter, Percutaneous (valvuloplasty) |
| Product Code | MAD |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Balloon | 1 |
| Total Device Problems | 3 |