# K163004: Radifocus Glidewire Advantage Track

- Pathway: 510(k) (Traditional)
- Applicant: Ashitaka Factory of Terumo Coporation
- Decided: Jan 30, 2017 after 94 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K863138 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122590: Radifocus Glidewire Advantage, Radifocus Glidewire Advantage, Terumo Medical Corporation (2013) Summary page 5.
- K063372: Radifocus Glidewire Advantage, Terumo Medical Corp. (2007) Summary page 5.

## Indications for use
The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

Source page: https://510kreport.com/device/K163004
Methodology: https://510kreport.com/methodology