Sentinel Cerebral Protection System

Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Sentinel Cerebral Protection System.

Pre-market Notification Details

Device IDK192460
510k NumberK192460
Device Name:Sentinel Cerebral Protection System
ClassificationTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Applicant Boston Scientific Corporation Three Scimed Place Maple Grove,  MN  55311 -1566
ContactEric Elliott
CorrespondentEric Elliott
Boston Scientific Corporation Three Scimed Place Maple Grove,  MN  55311 -1566
Product CodePUM  
CFR Regulation Number870.1251 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-09
Decision Date2020-02-19

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