# K200144: HI-TORQUE Steelcore Bare Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular
- Decided: Apr 8, 2020 after 77 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 K935997 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982876: HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282, Guidant Corp. (1998) Summary page 4.

## Indications for use
The Hi-Torque Steelcore™ Bare 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/K200144
Methodology: https://510kreport.com/methodology