# K982083: Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Sep 11, 1998 after 88 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.
194 later devices descend from it; 4 cite it directly.
3 of 195 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 its predicate without a number.
- (no number) ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire: named in the summary without a submission number

## Most influential descendants
- K990639: Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating. (1999), 189 descendants of its own
- K022762: Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 (2002), 104 descendants of its own
- K031277: Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 (2003), 92 descendants of its own
- K041531: Asahi Ptca Guide Wire Confianza Pro (2004), 79 descendants of its own
- K011986: Safe-Steer Guide Wire System (2002), 76 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). The wire is also intended to facilitate the placement of equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K982083
Methodology: https://510kreport.com/methodology