The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope's 10 Fr. Flexisheath Percutaneous Introducer.
| Device ID | K973007 |
| 510k Number | K973007 |
| Device Name: | DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-13 |
| Decision Date | 1997-11-06 |
| Summary: | summary |