GORE DrySeal Flex Introducer Sheath

Introducer, Catheter

W.L. GORE & ASSOCIATES, INC.

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.

Pre-market Notification Details

Device IDK160254
510k NumberK160254
Device Name:GORE DrySeal Flex Introducer Sheath
ClassificationIntroducer, Catheter
Applicant W.L. GORE & ASSOCIATES, INC. 1505 N FOURTH STREET Flagstaff,  AZ  86004
ContactMary Townsend
CorrespondentMary Townsend
W.L. GORE & ASSOCIATES, INC. 1505 N FOURTH STREET Flagstaff,  AZ  86004
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-01
Decision Date2016-05-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00733132628094 K160254 000

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