The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Intra-aortic Balloon Pump System 97 Modified.
| Device ID | K961509 |
| 510k Number | K961509 |
| Device Name: | INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Contact | Frank Casamassina |
| Correspondent | Frank Casamassina DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus, NJ 07653 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-19 |
| Decision Date | 1996-11-15 |