# K013833: HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating, #1009659,1009659J, 1009660, 10096

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Jan 16, 2002 after 58 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: 3 generations back to K913353 (1991). 6 ancestors in all.
26 later devices descend from it; 6 cite it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973494: HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance Middleweight Guide Wire with Hydg, Guidant Corp. (1997) Summary page 1.
- K002206: HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper MS Guide Wire with Hydrocoat Hydro, Guidant Corp. (2000) Summary page 1.

## Most influential descendants
- K072460: HI-Torque Balance Middleweight Universal II Guide Wire (2008), 21 descendants of its own
- K103101: HI-Torque Balance Middleweight Elite (2011), 13 descendants of its own
- 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

## 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/K013833
Methodology: https://510kreport.com/methodology