510(k) K080470 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Sep 12, 2008 |
| Received | Feb 21, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080470
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2024 | Maquet Medical Systems USA BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit. Open, Classified |
KFM | None listed |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc Rotaflow Centrifugal Pump
Custom tubing packs for the oxygenator Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.