The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Introducer Sheath With Silicone Pinch Valve.
| Device ID | K082356 |
| 510k Number | K082356 |
| Device Name: | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE |
| Classification | Introducer, Catheter |
| Applicant | W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LANE Flagstaff, AZ 86001 |
| Contact | Alicia Hemphill |
| Correspondent | Alicia Hemphill W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LANE Flagstaff, AZ 86001 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-18 |
| Decision Date | 2008-08-28 |
| Summary: | summary |