Fusion Quattro Extraction Balloon

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 Fusion Quattro Extraction Balloon.

Pre-market Notification Details

Device IDK200247
510k NumberK200247
Device Name:Fusion Quattro Extraction Balloon
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)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-31
Decision Date2020-02-27

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