510(k) K083111 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
IMPELLA 5.0 CATHETER FAMILY
| Applicant | Abiomed, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Apr 16, 2009 |
| Received | Oct 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083111
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2010 | Abiomed, Inc. Impella 5.0 Circulatory Support System
Catalog number: 004840
The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.