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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
510(k) Number K192460
Device Name Sentinel Cerebral Protection System
Applicant
Boston Scientific Corporation
Three Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Eric Elliott
Correspondent
Boston Scientific Corporation
Three Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Eric Elliott
Regulation Number870.1251
Classification Product Code
PUM  
Date Received09/09/2019
Decision Date 02/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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