# K193126: HI-TORQUE InfilTrac Guide Wire Family

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Dec 11, 2019 after 29 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: 7 generations back to K913353 (1991). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123067: Progress Guide Wire Family, Pilot Guide Wire Family, Abbott Vascular, Inc. (2013) Summary page 4.

## Most influential descendants
- K201834: HI-TORQUE PROCEED Guide Wire Family (2020), 0 descendants of its own

## Indications for use
Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).

Source page: https://510kreport.com/device/K193126
Methodology: https://510kreport.com/methodology