# K261715: Emboliner Embolic Protection System (EPC-03)

- Pathway: 510(k) (Traditional)
- Applicant: Emboline, Inc.
- Decided: Sep 8, 2026 after 109 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: 2 generations back to DEN160043 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192460: Sentinel Cerebral Protection System, Boston Scientific Corporation (2020) Summary page 5.

## Indications for use
The Emboliner Embolic Protection System is indicated for use as an embolic protection device to capture and remove embolic material during transcatheter aortic valve replacement (TAVR). Anatomical requirements for aortic diameters and femoral access site to sinotubular junction (STJ) distance should meet the requirement as specified in the Instructions for Use.

Source page: https://510kreport.com/device/K261715
Methodology: https://510kreport.com/methodology