meddevicedb.com FDA Device Reference

Sentinel Cerebral Protection System

DEN160043 Class II Direct
Decision Date
2017-06-01
Sponsor / Applicant
Claret Medical, Inc.

Technical Specification

510(k) Submission ID DEN160043
Product Code PUM
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1251
Decision Date 2017-06-01
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Sentinel Cerebral Protection System received FDA 510(k) clearance under submission number DEN160043, sponsored by Claret Medical, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-06-01.

Classification & Regulation

This clearance is catalogued under FDA product code PUM and 21 CFR 870.1251, within the Cardiovascular review panel as a Class II device.