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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biliary catheter for stone removal that may also allow for irrigation and contrast injection
510(k) Number K212582
Device Name SpyGlass Discover Balloon Dilation Catheter
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Laura Kuroski
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Laura (Kuroski) Meehan
Regulation Number876.5010
Classification Product Code
GCA  
Date Received08/16/2021
Decision Date 05/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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