# K101011: HI-Torque Balance Middleweight Universal

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular, Inc.
- Decided: May 24, 2010 after 42 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: 6 generations back to K913353 (1991). 13 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 18 devices in its family (counting itself) has 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.
- K072460: HI-Torque Balance Middleweight Universal II Guide Wire, Abbott Vascular, Inc. (2008) Summary page 1.
- K091825: HI-Torque Progress Guide Wire Family, Abbott Vascular, Inc. (2009) 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
- K121398: Charlie Guidewire (Regular), Charlie Guidewire (Stiff) (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K101011
Methodology: https://510kreport.com/methodology