# DEN160043: Sentinel Cerebral Protection System

- Pathway: De Novo (Direct)
- Applicant: Claret Medical, Inc.
- Decided: Jun 1, 2017 after 254 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
No predicates in its family tree.
2 later devices descend 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K192460: Sentinel Cerebral Protection System (2020), 1 descendant of its own
- 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/DEN160043
Methodology: https://510kreport.com/methodology