# K160785: Worker Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices, Inc.
- Decided: Dec 8, 2016 after 261 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K772021 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082094: Bard Ptfe (Teflon) Coated Guide Wires, C.R. Bard Inc., Bard Electrophysiology Division (2008) Summary page 4.

## Recalls of this device
- Dec 4, 2019 · Class I · Z-1792-2020: The stiffness of the soft end of the guidewire caused tissue perforation.
- Dec 4, 2019 · Class I · Z-1791-2020: The stiffness of the soft end of the guidewire caused tissue perforation.

## Indications for use
WORKER™ Guidewires are for use in facilitating the placement of catheters within the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K160785
Methodology: https://510kreport.com/methodology