# K083738: HI-Torque Flex-T Guide Wire, Models 1012067-01, 02, 03, 04 and 05

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Mar 11, 2009 after 85 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Hi-Torque Flex-T Guide Wire is intended for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels. The Hi-Torque Flex-T Guide Wire is not intended for use in coronary or neurovasculature.

Source page: https://510kreport.com/device/K083738
Methodology: https://510kreport.com/methodology