The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Supracor Intr-aortic Balloon Pump Console.
| Device ID | K070225 |
| 510k Number | K070225 |
| Device Name: | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE |
| Classification | System, Balloon, Intra-aortic And Control |
| 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 | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-24 |
| Decision Date | 2007-12-13 |
| Summary: | summary |