# K120480: Gore (R) Embolic Filter

- Pathway: 510(k) (Special)
- Applicant: W.L. Gore & Associates
- Decided: Mar 16, 2012 after 29 days
- Product code: NTE (Temporary Carotid Catheter For Embolic Capture)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003992 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103500: Gore Embolic Filter, W. L. Gore & Associates, Inc. (2011) Summary page 1.
- K042218: Accunet Embolic Protection System, RX Accunet Embolic Protection System, Guidant Corp. (2004) Summary page 1.

## Indications for use
The GORE® Embolic Filter system is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.

Source page: https://510kreport.com/device/K120480
Methodology: https://510kreport.com/methodology