The following data is part of a premarket notification filed by Datascope Corp. with the FDA for System 96 Intra-aortic Balloon Pump (iabp).
| Device ID | K965236 |
| 510k Number | K965236 |
| Device Name: | SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 580 WINTERS AVE. Paramus, NJ 07652 |
| Contact | William Goeller |
| Correspondent | William Goeller DATASCOPE CORP. 580 WINTERS AVE. Paramus, NJ 07652 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-31 |
| Decision Date | 1997-07-01 |