K082356 is an FDA 510(k) clearance for the GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on August 28, 2008, 10 days after receiving the submission on August 18, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K082356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2008 |
| Decision Date | August 28, 2008 |
| Days to Decision | 10 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |