# K982876: HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Nov 10, 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
Longest line of descent: 2 generations back to K935997 (1994). 5 ancestors in all.
34 later devices descend from it; 3 cite it directly.
3 of 40 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 2.
- K945379: Platinum Plus Guidewire with Hydrophilic Coating, Boston Scientific Corp (1995) Summary page 2.

## Most influential descendants
- K061984: Treasure (2006), 32 descendants of its own
- K071721: Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 (2007), 27 descendants of its own
- K103057: Asahi Astato XS 20 Peripheral Guide Wire (2010), 21 descendants of its own
- K083146: Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000 (2008), 17 descendants of its own
- K150445: ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) (2015), 16 descendants of its own

## Indications for use
The HI-TORQUE STEELCORE™ 18 Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K982876
Methodology: https://510kreport.com/methodology
