# K201834: HI-TORQUE PROCEED Guide Wire Family

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Jul 30, 2020 after 28 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193126: HI-TORQUE InfilTrac Guide Wire Family, Abbott Vascular (2019) Summary page 4.

## Indications for use
This guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal, and infrapopliteal arteries. 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.

Source page: https://510kreport.com/device/K201834
Methodology: https://510kreport.com/methodology