# K192460: Sentinel Cerebral Protection System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Feb 19, 2020 after 163 days
- Product code: PUM (Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures)
- Device class: 2
- Regulation: 21 CFR 870.1251
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160043 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160043: Sentinel Cerebral Protection System, Claret Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- K261715: Emboliner Embolic Protection System (EPC-03) (2026), 0 descendants of its own

## Indications for use
The Sentinel Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 – 15 mm for the brachiocephalic and 6.5 – 10 mm in the left common carotid.

Source page: https://510kreport.com/device/K192460
Methodology: https://510kreport.com/methodology