# K980294: Acs HI-Torque Super Sport Guide Wire with Hydrocoat Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Apr 24, 1998 after 87 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: 3 generations back to K913353 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963702: Acs HI-Torque Iron Man Guide Wire, Advanced Cardiovascular Systems, Inc. (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.

## Indications for use
The ACS HI-TORQUE?® SUPER S’PORT™ Guide Wire with Hydrocoatm Hydrophilic Coating is steerable wire intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ACS HI-TORQUE?® SUPER S’PORT™ Guide Wire with Hydrocoat Hydrophilic Coating is also intended to facilitate the placement of equipment, such as atherectomy and stent devices, during other diagnostic and therapeutic intravascular procedures.

Source page: https://510kreport.com/device/K980294
Methodology: https://510kreport.com/methodology