# K021228: HI-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and the Balance Middleweight Universal Guide

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: May 15, 2002 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
No predicates in its family tree.
22 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K030617: PT2 Guide Wire and Addwire Extension Wire (2003), 11 descendants of its own
- K143587: ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire (2015), 6 descendants of its own
- K122573: HI-Torque Command Guide Wire Family (2012), 6 descendants of its own
- K032183: IQ Hydrophilic Guide Wire (2003), 4 descendants of its own
- K040140: IQ Guide Wire (2004), 3 descendants of its own

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

Source page: https://510kreport.com/device/K021228
Methodology: https://510kreport.com/methodology