# K142415: Hi-Torque JET Guide Wire Family

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular, Inc.
- Decided: Dec 19, 2014 after 113 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: 8 generations back to K913353 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122573: HI-Torque Command Guide Wire Family, Abbott Vascular, Inc. (2012) Summary page 4.
- K112957: HI-Torque Powerturn, Abbott Vascular-Cardiac Therapies (2011) Summary page 4.

## Indications for use
This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures. The guide wire may also 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.

Source page: https://510kreport.com/device/K142415
Methodology: https://510kreport.com/methodology