Advanix Biliary Stent With NaviFlex RX Delivery System

Stents, Drains And Dilators For The Biliary Ducts

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Advanix Biliary Stent With Naviflex Rx Delivery System.

Pre-market Notification Details

Device IDK203162
510k NumberK203162
Device Name:Advanix Biliary Stent With NaviFlex RX Delivery System
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactElena Hennessey
CorrespondentElena Hennessey
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-23
Decision Date2020-12-18

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