510(k) K110845 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
IMPELLA CONTROLLER WITH FLOW CONTROL
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Apr 27, 2011 |
| Received | Mar 28, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110845
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.