# K984394: Acs HI-Torque Wiggle Guide Wire with Microglide Coating

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Mar 8, 1999 after 90 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 K883000 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913353: Vascular Guide Wire, Advanced Cardiovascular Systems, Inc. (1991) Summary page 1.
- K883000: Acs Angioscope Guide Wire, Advanced Cardiovascular Systems, Inc. (1988) Summary page 1.

## Indications for use
The intended use of the ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating is to facilitate the placement of the catheter by orienting the catheter tip during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and other interventional diagnostic or therapeutic procedures.

Source page: https://510kreport.com/device/K984394
Methodology: https://510kreport.com/methodology