Not Cleared Direct

DEN160043 - Sentinel Cerebral Protection System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160043 · Claret Medical, Inc. · Cardiovascular device
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Jun 2017
Decision
254d
Days
Class 2
Risk

DEN160043 is an FDA 510(k) submission (not cleared) for the Sentinel Cerebral Protection System. Classified as Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures (product code PUM), Class II - Special Controls.

Submitted by Claret Medical, Inc. (Santa Rosa, US). The FDA issued a Not Cleared (DENG) decision on June 1, 2017 after a review of 254 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1251 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 254 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Claret Medical, Inc. devices

Submission Details

510(k) Number DEN160043 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 20, 2016
Decision Date June 01, 2017
Days to Decision 254 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 125d · This submission: 254d
Pathway characteristics

Device Classification

Product Code PUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1251
Definition Embolic Protection For Transcatheter Intracardiac Procedures
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.