# K974773: HI-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Standard Guide Wire with Hydrocoat Hydrophilic

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Mar 13, 1998 after 81 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.
105 later devices descend from it; 4 cite it directly.
3 of 106 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) HI-TORQUE FLOPPY® Guide Wire with MICROGLIDE® Coating: named in the summary without a submission number
- (no number) HI-TORQUE STANDARD® Guide Wire with MICROGLIDE® Coating: named in the summary without a submission number
- (no number) HI-TORQUE INTERMEDIATE® Guide Wire with MICROGLIDE® Coating: named in the summary without a submission number
- (no number) HI-TORQUE APPROACH® Guide Wire with MICROGLIDE® Coating: named in the summary without a submission number
- (no number) HI-TORQUE FLOPPY II® Guide Wire with MICROGLIDE® Coating: named in the summary without a submission number
- (no number) HI-TORQUE TRAVERSE® Guide Wire with MICROGLIDE® Coating: named in the summary without a submission number
- (no number) ACS HI-TORQUE EXTRA S’PORT™ Guide Wire with MICROGLIDE® Coating: named in the summary without a submission number
- (no number) HI-TORQUE FLOPPY® EXTRA SUPPORT Guide Wire with MICROGLIDE® Coating: named in the summary without a submission number
- (no number) HI-TORQUE FLOPPY II® EXTRA SUPPORT Guide Wire with MICROGLIDE® Coating: named in the summary without a submission number
- (no number) ACS HI-TORQUE IRON MAN® Guide Wire with MICROGLIDE® Coating: named in the summary without a submission number
- (no number) ChoICE™ PT Plus Guide Wire: named in the summary without a submission number

## Most influential descendants
- 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
- K052339: Asahi Ptca Guide Wire (2005), 60 descendants of its own
- K052022: Asahi Ptca Guide Wire Fielder (2005), 59 descendants of its own

## Indications for use
Facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ACS HI-TORQUE EXTRA S’PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE IRON MANT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are 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/K974773
Methodology: https://510kreport.com/methodology