# K991152: HI-Torque Balance Trek Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Apr 29, 1999 after 23 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: 1 generation back to K982083 (1998). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982083: Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic Coating, Guidant Corp. (1998) 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
The intended use for the HI-TORQUE BALANCE TREK™ Guide Wires with HYDROCOAT™ Hydrophilic Coating is: To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K991152
Methodology: https://510kreport.com/methodology