K063723 is an FDA 510(k) clearance for the IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II - Special Controls, product code KFM).
Submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on May 30, 2008, 532 days after receiving the submission on December 15, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4360.
| 510(k) Number | K063723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2006 |
| Decision Date | May 30, 2008 |
| Days to Decision | 532 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KFM - Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4360 |