# K101648: HI-Torque Winn Guide Wire Family

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular, Inc.
- Decided: Jul 8, 2010 after 27 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091825: HI-Torque Progress Guide Wire Family, Abbott Vascular, Inc. (2009) Summary page 1.

## Indications for use
This Hi-Torque guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous translumninal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

Source page: https://510kreport.com/device/K101648
Methodology: https://510kreport.com/methodology