# K112957: HI-Torque Powerturn

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular-Cardiac Therapies
- Decided: Nov 8, 2011 after 35 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: 6 generations back to K913353 (1991). 16 ancestors in all.
7 later devices descend from it; 2 cite it directly.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060449: HI-Torque Advance and Advance Lite Guide Wire, Guidant Corporation (2006) Summary page 1.
- K103101: HI-Torque Balance Middleweight Elite, Abbott Vascular-Cardiac Therapies (2011) Summary page 1.
- K091582: GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15, Medtronic Vascular (2009) Summary page 1.

## Most influential descendants
- 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
- K250552: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (2025), 0 descendants of its own
- K191502: Heraeus Peripheral Guidewire (2019), 0 descendants of its own

## Indications for use
This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transiumninal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). 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/K112957
Methodology: https://510kreport.com/methodology