Sentinel Cerebral Protection System— 510(k) K192460

Name: FDA 510(k) clearance K192460
Creator: U.S. Food and Drug Administration
Published: 2020-02-19

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K192460 for Sentinel Cerebral Protection System, Substantially Equivalent on 2020-02-19. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code PUM
Device class: Class 2
Regulation: 21 CFR 870.1251
Advisory panel: Cardiovascular
Date received: 2019-09-09
Decision date: 2020-02-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PUM

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K261715 — Emboliner Embolic Protection System (EPC-03)2026-09-08
DEN160043 — Sentinel Cerebral Protection System2017-06-01

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Adverse events under product code PUM

product code PUM

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.