K160254 is an FDA 510(k) clearance for the GORE DrySeal Flex Introducer Sheath. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by W.L. Gore & Associates, Inc. (Phoenix, US). The FDA issued a Cleared decision on May 12, 2016, 101 days after receiving the submission on February 1, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K160254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2016 |
| Decision Date | May 12, 2016 |
| Days to Decision | 101 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 |