Ureteral Stent Systems, Biliary Drainage Catheters

Stent, Ureteral

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ureteral Stent Systems, Biliary Drainage Catheters.

Pre-market Notification Details

Device IDK191446
510k NumberK191446
Device Name:Ureteral Stent Systems, Biliary Drainage Catheters
ClassificationStent, Ureteral
Applicant Boston Scientific Corporation 300 Boston Scientific Way Marlborough,  MA  01752
ContactJois Zuniga Gamboa
CorrespondentJois Zuniga Gamboa
Boston Scientific Corporation 300 Boston Scientific Way Marlborough,  MA  01752
Product CodeFAD  
CFR Regulation Number876.4620 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-31
Decision Date2020-01-02

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