Atlas FDA

Sentinel Cerebral Protection System

FDA 510(k) clearance K192460 · decided 2020-02-19

Clearance details

K-number
K192460
Device name
Sentinel Cerebral Protection System
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2019-09-09
Decision date
2020-02-19
Days to decision
163 days
Clearance type
Special
Product code
PUM
Device class
2
Regulation number
870.1251
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Sentinel Cerebral Protection System (DEN160043)Claret Medical, Inc.2017-06-01

Recalls involving this device

No recalls on record reference this clearance.

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