IMPELLA CONTROLLER
Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
ABIOMED, INC.
The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Impella Controller.
Pre-market Notification Details
| Device ID | K093801 |
| 510k Number | K093801 |
| Device Name: | IMPELLA CONTROLLER |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-10 |
| Decision Date | 2010-07-08 |
| Summary: | summary |
Trademark Results [IMPELLA CONTROLLER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMPELLA CONTROLLER 88499544 not registered Live/Pending |
Abiomed, Inc. 2019-07-03 |
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