| Device Type ID | 884 |
| Device Name | Rotator, Prosthetic Heart Valve |
| Regulation Description | Prosthetic Heart Valve Holder. |
| 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 | 870.3935 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MOP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 884 |
| Device | Rotator, Prosthetic Heart Valve |
| Product Code | MOP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Prosthetic Heart Valve Holder. |
| CFR Regulation Number | 870.3935 [🔎] |