# K083706: HI-Torque Versacore Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Feb 6, 2009 after 53 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 its predicate without a number.
- (no number) Mallinckrodt branded Wholey Hi-Torque Guide Wire: named in the summary without a submission number

## Indications for use
The Hi-Torque Versacore 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 Versacore Guide Wire is not intended for use in coronary or neurovasculature.

Source page: https://510kreport.com/device/K083706
Methodology: https://510kreport.com/methodology