# K091582: GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Dec 4, 2009 after 185 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: 1 generation back to K970466 (1997). 2 ancestors in all.
10 later devices descend from it; 3 cite it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001969: GT2 Fusion Guide Wire, Model NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300, Medtronic Vascular (2000)
- K970466: Radius Ptca Guidewire, Radius Medical Technologies, Inc. (1997) Summary page 1.

## Most influential descendants
- K112957: HI-Torque Powerturn (2011), 7 descendants of its own
- K122573: HI-Torque Command Guide Wire Family (2012), 6 descendants of its own
- K240997: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (2024), 1 descendant of its own
- K152404: Hi-Torque Command 18 Guide Wire (2015), 1 descendant of its own
- K100470: GTX 12 Gidewire (2010), 1 descendant 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/K091582
Methodology: https://510kreport.com/methodology