The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Impella 5.0 Catheter Family.
| Device ID | K083111 |
| 510k Number | K083111 |
| Device Name: | IMPELLA 5.0 CATHETER FAMILY |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | ABIOMED, INC. 22 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | William Bolt |
| Correspondent | William Bolt ABIOMED, INC. 22 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-21 |
| Decision Date | 2009-04-16 |
| Summary: | summary |