# K103101: HI-Torque Balance Middleweight Elite

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular-Cardiac Therapies
- Decided: Feb 10, 2011 after 113 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: 5 generations back to K913353 (1991). 11 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971815: Asc Balance Middleweight Guide Wire, Guidant Corp. (1997) Summary page 1.
- 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.
- K072460: HI-Torque Balance Middleweight Universal II Guide Wire, Abbott Vascular, Inc. (2008) Summary page 1.
- K063695: Runthrough NS, Terumo Medical Corp. (2007) Summary page 1.

## Most influential descendants
- K112957: HI-Torque Powerturn (2011), 7 descendants of its own
- K122573: HI-Torque Command Guide Wire Family (2012), 6 descendants of its own
- K152709: HI-Torque Balance (2015), 2 descendants of its own
- K240997: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (2024), 1 descendant of its own
- K152404: Hi-Torque Command 18 Guide Wire (2015), 1 descendant of its own

## Indications for use
This Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

Source page: https://510kreport.com/device/K103101
Methodology: https://510kreport.com/methodology