# K123156: Gore Flow Reversal System Model GFRS073

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Dec 13, 2012 after 65 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). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083300: Gore Flow Reversal System, W. L. Gore & Associates, Inc. (2009) Summary page 2.

## Indications for use
The GORE® Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for the patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below: * Adequate iliac/femoral access * Common carotid artery diameters between 6 and 12 mm * External carotid artery diameters less than 6 mm

Source page: https://510kreport.com/device/K123156
Methodology: https://510kreport.com/methodology