# K103500: Gore Embolic Filter

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 23, 2011 after 175 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: 5 generations back to K003992 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063204: Spiderfx Embolic Protection Device, Ev3, Inc. (2006) Summary page 1.
- K042218: Accunet Embolic Protection System, RX Accunet Embolic Protection System, Guidant Corp. (2004) Summary page 1.

## Most influential descendants
- K120480: Gore (R) Embolic Filter (2012), 0 descendants of its own

## 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/K103500
Methodology: https://510kreport.com/methodology