# K240859: Glidewire GT-R

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corporation
- Decided: Aug 21, 2024 after 146 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: 2 generations back to K863138 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170417: Glidewire GT, Terumo Corporation (2017) Summary page 5.

## Indications for use
The Glidewire GT-R is intended 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/K240859
Methodology: https://510kreport.com/methodology