Definition: The Device Is Used To Stabilize, Move, Lift, And Position The Heart During Cardiovascular Surgery.
| Device Type ID | 918 |
| Device Name | Stabilizer, Heart, Non-compression, Reprocessed |
| Regulation Description | Cardiovascular Surgical Instruments. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.4500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NQG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 918 |
| Device | Stabilizer, Heart, Non-compression, Reprocessed |
| Product Code | NQG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cardiovascular Surgical Instruments. |
| CFR Regulation Number | 870.4500 [🔎] |