# K100470: GTX 12 Gidewire

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Apr 21, 2010 after 62 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970466 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091582: GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15, Medtronic Vascular (2009) Summary page 1.

## Most influential descendants
- K140695: Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition Guidewire (2014), 0 descendants of its own

## Recalls of this device
- Oct 21, 2013 · Class I · Z-0264-2014: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnos

## Indications for use
Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Source page: https://510kreport.com/device/K100470
Methodology: https://510kreport.com/methodology