# K980119: Acs HI-Torque Wholey Supra Core Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Mar 20, 1998 after 66 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: 1 generation back to K852123 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852123: Wholey HI-Torque Guide Wires, Advanced Cardiovascular Systems, Inc. (1985) Summary page 1.
- K861765: Acs Wholey HI-Torque Guide Wire, Advanced Cardiovascular Systems, Inc. (1986) Summary page 1.
- K915554: HI-Torque Sport-T (TM) Guide Wire, Peripheral Systems Group (1993) Summary page 1.
- K942382: MS Amplatz Extra Stiff Guide Wire, Meadox Surgimed, Inc. (1994) Summary page 1.

## Indications for use
The ACS HI-TORQUE WHOLEY SUPRA CORE™ 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/K980119
Methodology: https://510kreport.com/methodology