The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Profile 8fr. Alt B Iab, 34cc, Datascope Profile 8fr. Alt B Iab, 40cc, Model 0684-000319, 0684-00-0320.
| Device ID | K003598 |
| 510k Number | K003598 |
| Device Name: | DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Joann Wolf |
| Correspondent | Joann Wolf DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-21 |
| Decision Date | 2000-12-21 |