# K152709: HI-Torque Balance

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Oct 21, 2015 after 30 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: 7 generations back to K913353 (1991). 22 ancestors in all.
2 later devices descend from it; 2 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)
- K925381: Acs HI-Torque Balance (TM) Guide Wire, Advanced Cardiovascular Systems, Inc. (1993) Summary page 10.
- K973494: HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance Middleweight Guide Wire with Hydg, Guidant Corp. (1997) Summary page 10.
- K021228: HI-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and the Balance Middleweight Universal Guide, Guidant Corp. (2002) Summary page 10.
- K991152: HI-Torque Balance Trek Guide Wire, Guidant Corp. (1999) Summary page 12.
- K982083: Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic Coating, Guidant Corp. (1998) Summary page 14.
- K971815: Asc Balance Middleweight Guide Wire, Guidant Corp. (1997) Summary page 16.
- K013833: HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating, #1009659,1009659J, 1009660, 10096, Guidant Corp. (2002) Summary page 18.
- K031678: HI-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating, Guidant Corp. (2003) Summary page 18.
- K101011: HI-Torque Balance Middleweight Universal, Abbott Vascular, Inc. (2010) Summary page 18.
- K072460: HI-Torque Balance Middleweight Universal II Guide Wire, Abbott Vascular, Inc. (2008) Summary page 20.
- K103101: HI-Torque Balance Middleweight Elite, Abbott Vascular-Cardiac Therapies (2011) Summary page 22.

## Most influential descendants
- K182553: Inno-Pathwire (2019), 0 descendants of its own
- K173052: Heraeus TMW Guidewire (2017), 0 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). To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). 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. 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/K152709
Methodology: https://510kreport.com/methodology