The following data is part of a premarket notification filed by W.l. Gore & Associates, Inc. with the FDA for Gore Dryseal Flex Introducer Sheath.
| Device ID | K160254 |
| 510k Number | K160254 |
| Device Name: | GORE DrySeal Flex Introducer Sheath |
| Classification | Introducer, Catheter |
| Applicant | W.L. GORE & ASSOCIATES, INC. 1505 N FOURTH STREET Flagstaff, AZ 86004 |
| Contact | Mary Townsend |
| Correspondent | Mary Townsend W.L. GORE & ASSOCIATES, INC. 1505 N FOURTH STREET Flagstaff, AZ 86004 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-05-12 |
| Summary: | summary |