WallFlex Biliary RX Fully Covered Stent System RMV

Biliary Stent System For Benign Strictures

BOSTON SCIENTIFIC

The following data is part of a De Novo classification by Boston Scientific with the FDA for Wallflex Biliary Rx Fully Covered Stent System Rmv.

Pre-market Notification Details

DeNovo IDDEN150040
Device Name:WallFlex Biliary RX Fully Covered Stent System RMV
ClassificationBiliary Stent System For Benign Strictures
Applicant BOSTON SCIENTIFIC 100 Boston Scientific Way Marlborough,  MA  01752
ContactThomas Hirte
Product CodePNB  
CFR Regulation Number876.5011 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
TypeDirect
Date Received2015-08-28
Decision Date2016-06-03
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08714729953197 DEN150040 000
08714729953180 DEN150040 000
08714729953173 DEN150040 000
08714729953166 DEN150040 000
08714729953159 DEN150040 000

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