# K140536: HI Torque Connect Guidewire, HI Torque Connect Flex Guidewire, HI Torque Connect 250T Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Medical
- Decided: Dec 17, 2014 after 288 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 K890505 (1989). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112381: HI Torque Connect Guidewire, Lake Region Medical (2011) Summary page 5.

## Indications for use
Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

Source page: https://510kreport.com/device/K140536
Methodology: https://510kreport.com/methodology