# K083300: Gore Flow Reversal System

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Feb 4, 2009 after 86 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). 27 ancestors in all.
5 later devices descend from it; 3 cite it directly.
2 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021210: Arteria Occlusion Balloon, Arteria Medical Science, Inc. (2002) Summary page 1.
- K021293: Arteria Blood Filter, Arteria Medical Science, Inc. (2002) Summary page 1.
- K070770: Gore Balloon Sheath, W. L. Gore & Associates, Inc. (2007) Summary page 1.
- K072990: Guardwire Temporary Occlusion and Aspiration System- Carotid, Medtronic, Inc. (2007) Summary page 1.

## Most influential descendants
- K143072: ENROUTE Transcarotid Neuroprotection System (2015), 2 descendants of its own
- K153485: ENROUTE Transcarotid Neuroprotection System (2016), 1 descendant of its own
- K230402: ENROUTE® Transcarotid Neuroprotection System (2023), 0 descendants of its own
- K123156: Gore Flow Reversal System Model GFRS073 (2012), 0 descendants of its own
- K092177: MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6 (2009), 0 descendants of its own

## 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/K083300
Methodology: https://510kreport.com/methodology