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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00733132630950 | K160254 | 000 |
00733132628117 | K160254 | 000 |
00733132629985 | K160254 | 000 |
00733132629978 | K160254 | 000 |
00733132629961 | K160254 | 000 |
00733132628346 | K160254 | 000 |
00733132628322 | K160254 | 000 |
00733132628308 | K160254 | 000 |
00733132628285 | K160254 | 000 |
00733132628261 | K160254 | 000 |
00733132628360 | K160254 | 000 |
00733132628384 | K160254 | 000 |
00733132630103 | K160254 | 000 |
00733132630073 | K160254 | 000 |
00733132630066 | K160254 | 000 |
00733132630042 | K160254 | 000 |
00733132630028 | K160254 | 000 |
00733132630011 | K160254 | 000 |
00733132630004 | K160254 | 000 |
00733132628421 | K160254 | 000 |
00733132628407 | K160254 | 000 |
00733132628094 | K160254 | 000 |