SpyGlass Discover Balloon Dilation Catheter

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Spyglass Discover Balloon Dilation Catheter.

Pre-market Notification Details

Device IDK212582
510k NumberK212582
Device Name:SpyGlass Discover Balloon Dilation Catheter
ClassificationBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactLaura Kuroski
CorrespondentLaura (kuroski) Meehan
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodeGCA  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-16
Decision Date2022-05-06

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