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 |