Cleared Special

K192460 - Sentinel Cerebral Protection System (FDA 510(k) Clearance)

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

K192460 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
163d
Days
Class 2
Risk

K192460 is an FDA 510(k) clearance for the Sentinel Cerebral Protection System. Classified as Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures (product code PUM), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on February 19, 2020 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1251 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K192460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2019
Decision Date February 19, 2020
Days to Decision 163 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Modification to existing cleared device.

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.