# K021285: HI-Torque Extra S'port Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: May 2, 2002 after 14 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: 2 generations back to K952860 (1995). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983033: Acs HT Balance Middleweight Guide Wire, Guidant Corp. (1998) Summary page 1.

## Most influential descendants
- K023300: HI-Torque Whisper LS; HI-Torque Whisper MS; HI-Torque Whisper MS CS-J; HI-Torque Whisper ES; HI-Torque Whisper ES CS-J (2002), 1 descendant of its own
- K052965: Easytrak 2 Stylet, Models 4826, 4829, 4832. (2006), 0 descendants of its own
- K041762: Finishing Wire Supportrak (2004), 0 descendants of its own

## Indications for use
The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic and/or therapeutic procedures.

Source page: https://510kreport.com/device/K021285
Methodology: https://510kreport.com/methodology