# K971815: Asc Balance Middleweight Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Jul 9, 1997 after 54 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 K913353 (1991). 2 ancestors in all.
53 later devices descend from it; 5 cite it directly.
2 of 56 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 2.
- K913353: Vascular Guide Wire, Advanced Cardiovascular Systems, Inc. (1991) Summary page 3.

## Most influential descendants
- K973494: HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance Middleweight Guide Wire with Hydg (1997), 43 descendants of its own
- K013833: HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating, #1009659,1009659J, 1009660, 10096 (2002), 26 descendants of its own
- K072460: HI-Torque Balance Middleweight Universal II Guide Wire (2008), 21 descendants of its own
- K103101: HI-Torque Balance Middleweight Elite (2011), 13 descendants of its own
- K030617: PT2 Guide Wire and Addwire Extension Wire (2003), 11 descendants of its own

## Indications for use
The ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is a steerable wire intended 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 intravascular procedures.

Source page: https://510kreport.com/device/K971815
Methodology: https://510kreport.com/methodology