The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Impella 2.5 Plus Catheter.
| Device ID | K112892 |
| 510k Number | K112892 |
| Device Name: | IMPELLA 2.5 PLUS CATHETER |
| Classification | Temporary Cardiac Support Blood Pump |
| Applicant | ABIOMED, INC. 22 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Carolyn Pekar |
| Correspondent | Carolyn Pekar ABIOMED, INC. 22 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | PBL |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-09-06 |
| Summary: | summary |