Pittsburgh, PA, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QOH | Extracorporeal System For Carbon Dioxide Removal | Class II | Cardiovascular | 1 | 2021-11-13 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-12-18 | Class II | Terminated | Z-0938-2021 | ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: a… | — | CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccurac… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2021-11-13 | DEN210006 | Hemolung Respiratory Assist System | QOH | Class II | Cardiovascular |