The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Impella Recover Lp 2.5 Percutaneous Cardiac Support System.
| Device ID | K063723 |
| 510k Number | K063723 |
| Device Name: | IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | ABIOMED, INC. 22 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Robert T Kung |
| Correspondent | Robert T Kung ABIOMED, INC. 22 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | KFM |
| Subsequent Product Code | DQO |
| Subsequent Product Code | DWF |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-15 |
| Decision Date | 2008-05-30 |
| Summary: | summary |