# K250552: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Jul 25, 2025 after 150 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: 9 generations back to K913353 (1991). 24 ancestors in all.
No later device cites it as a predicate yet.
2 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240997: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire, Abbott Medical (2024) Summary page 5.

## Indications for use
The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures. The guide wires 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/K250552
Methodology: https://510kreport.com/methodology