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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name gallbladder drainage stent and delivery system
De Novo Number DEN230019
Device Name AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)
Requester
Boston Scientific Corporation
100 boston scientific way
marlborough,  MD  01752
Contact alexis erazo
Regulation Number876.5016
Classification Product Code
QXH  
Date Received03/27/2023
Decision Date 08/18/2023
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
Type Direct
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