The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Modification To Datascope Profile 8fr. Iab, 34cc; Modification To Datascope Profile 8fr. Iab, 40cc.
| Device ID | K002949 |
| 510k Number | K002949 |
| Device Name: | MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Joanne Wolf |
| Correspondent | Joanne 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 | 2000-09-21 |
| Decision Date | 2000-10-20 |