510(k) K090515 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
| Applicant | Maquet Cardiopulmonary, AG, Hirrlingen, DE |
| Decision | Substantially Equivalent, Dec 18, 2009 |
| Received | Feb 26, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090515
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2024 | Maquet Medical Systems USA BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit. Open, Classified |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.