GORE DRYSEAL 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 Sheath.

Pre-market Notification Details

Device IDK093791
510k NumberK093791
Device Name:GORE DRYSEAL SHEATH
ClassificationIntroducer, Catheter
Applicant W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LANE Flagstaff,  AZ  86001 -0500
ContactAlicia Hemphill
CorrespondentAlicia Hemphill
W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LANE Flagstaff,  AZ  86001 -0500
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-10
Decision Date2010-03-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.