The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Modification To: Datascope 8fr. Polyimide Alt B Iab, 25cc, 34cc, 40cc, Datascope Insertion Kit For 8 Fr, Polyimide Alt B.
| Device ID | K013326 |
| 510k Number | K013326 |
| Device Name: | MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B |
| 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 | 2001-10-05 |
| Decision Date | 2001-11-02 |
| Summary: | summary |