# K031678: HI-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Aug 26, 2003 after 88 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: 4 generations back to K913353 (1991). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013833: HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating, #1009659,1009659J, 1009660, 10096, Guidant Corp. (2002) Summary page 1.

## Most influential descendants
- K152709: HI-Torque Balance (2015), 2 descendants of its own
- K182553: Inno-Pathwire (2019), 0 descendants of its own
- K173052: Heraeus TMW Guidewire (2017), 0 descendants of its own

## Indications for use
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

Source page: https://510kreport.com/device/K031678
Methodology: https://510kreport.com/methodology