# K981936: Abd Varisoft Steerable Guide Wire and Abd Varisoft Guide Wire Extension

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Biomedical Devices, Inc.
- Decided: Feb 16, 2000 after 624 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
INTENDED USE. The VariSoft Guide Wire is intended to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA. The VariSoft Guide Wire is not intended for use in the cerebral vasculature. INTENDED USE. The ABD VariSoft Guide Wire Extension is intended to provide the necessary length to allow the exchange of one dilatation catheter for another while maintaining the position of the ABD VariSoft Steerable Guide Wire in the coronary artery. After the dilatation catheter exchange has been completed, the ABD VariSoft Guide Wire Extension can be detached and the ABD VariSoft Steerable Guide Wire can be used as a conventional steerable guide wire.

Source page: https://510kreport.com/device/K981936
Methodology: https://510kreport.com/methodology