Tri-Ex Extraction Balloon With Multiple Sizing

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

WILSON-COOK MEDICAL, INC

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Tri-ex Extraction Balloon With Multiple Sizing.

Pre-market Notification Details

Device IDK170292
510k NumberK170292
Device Name:Tri-Ex Extraction Balloon With Multiple Sizing
ClassificationBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Applicant WILSON-COOK MEDICAL, INC 4900 BETHANIA STATION ROAD Winston-salem,  NC  27105
ContactTiffanny A. Thomas
CorrespondentTiffanny A. Thomas
WILSON-COOK MEDICAL, INC 4900 BETHANIA STATION ROAD Winston-salem,  NC  27105
Product CodeGCA  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-31
Decision Date2017-09-20
Summary:summary

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