Pittsburgh, PA, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QNR | — | — | — | 3 | 2024-01-19 |
| PZS | Dual Lumen Ecmo Cannula | Class II | Cardiovascular | 1 | 2023-10-06 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | Class II | Cardiovascular | 1 | 2023-08-03 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-01-19 | K233736 | LifeSPARC System | QNR | — | — |
| 2023-10-06 | K232480 | ProtekDuo Veno-Venous Cannula Sets | PZS | Class II | Cardiovascular |
| 2023-08-03 | K232132 | LifeSPARC System | KFM | Class II | Cardiovascular |
| 2022-11-15 | K211830 | LifeSPARC System | QNR | — | — |
| 2021-03-26 | K202751 | TandemHeart Pump and Escort Controller | QNR | — | — |