The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope 8fr. Co-lumen 34 And 40cc Intra-aortic Balloon Catheters For Optional Sheathless Insertion With Accessories.
| Device ID | K980385 |
| 510k Number | K980385 |
| Device Name: | DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES |
| 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 | 1998-02-02 |
| Decision Date | 1998-05-01 |
| Summary: | summary |