| Device Type ID | 786 |
| Device Name | Sizer, Heart-valve, Prosthesis |
| Regulation Description | Prosthetic Heart Valve Sizer. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 870.3945 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | DTI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 786 |
| Device | Sizer, Heart-valve, Prosthesis |
| Product Code | DTI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Prosthetic Heart Valve Sizer. |
| CFR Regulation Number | 870.3945 [🔎] |
| Device Problems | |
|---|---|
Fracture | 3 |
Appropriate Term/Code Not Available | 1 |
Material Fragmentation | 1 |
Crack | 1 |
| Total Device Problems | 6 |