510(k) K093801 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
IMPELLA CONTROLLER
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Jul 8, 2010 |
| Received | Dec 10, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093801
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.