The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Impella Controller With Flow Control.
| Device ID | K110845 |
| 510k Number | K110845 |
| Device Name: | IMPELLA CONTROLLER WITH FLOW CONTROL |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | ABIOMED, INC. 22 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Robert Stewart |
| Correspondent | Robert Stewart ABIOMED, INC. 22 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-28 |
| Decision Date | 2011-04-27 |
| Summary: | summary |