# K060449: HI-Torque Advance and Advance Lite Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corporation
- Decided: May 30, 2006 after 98 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.
18 later devices descend from it; 2 cite it directly.
1 of 19 devices in its family (counting itself) has 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) ACS 0.014" Hi-Torque Floppy PATHFINDER Guide Wire: named in the summary without a submission number

## Most influential descendants
- K091825: HI-Torque Progress Guide Wire Family (2009), 9 descendants of its own
- K112957: HI-Torque Powerturn (2011), 7 descendants of its own
- K122573: HI-Torque Command Guide Wire Family (2012), 6 descendants of its own
- K101011: HI-Torque Balance Middleweight Universal (2010), 4 descendants of its own
- K152709: HI-Torque Balance (2015), 2 descendants of its own

## Indications for use
To facilitate the placement of interventional percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

Source page: https://510kreport.com/device/K060449
Methodology: https://510kreport.com/methodology