K973007 is an FDA 510(k) clearance for the DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on November 6, 1997, 85 days after receiving the submission on August 13, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K973007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1997 |
| Decision Date | November 06, 1997 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |