The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope's 8fr. Polymide 25cc,34cc And 40cc Iab And Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329.
| Device ID | K994157 |
| 510k Number | K994157 |
| Device Name: | DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Whitney Torning |
| Correspondent | Whitney Torning DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-09 |
| Decision Date | 2000-03-13 |
| Summary: | summary |