The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope 7.5fr. Iab Catheter And Accessories.
| Device ID | K041281 |
| 510k Number | K041281 |
| Device Name: | DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Joann Taylor |
| Correspondent | Joann Taylor 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 | 2004-05-13 |
| Decision Date | 2004-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607567106649 | K041281 | 000 |
| 10607567106632 | K041281 | 000 |