# K141218: Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire System

- Pathway: 510(k) (Traditional)
- Applicant: Vadiswire Corporation
- Decided: Dec 18, 2014 after 220 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: 2 generations back to K933334 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053251: Techdevice Guidewire, Techdevice Corporation (2006) Summary page 5.
- K942382: MS Amplatz Extra Stiff Guide Wire, Meadox Surgimed, Inc. (1994) Summary page 5.

## Indications for use
The ZigiWire Guidewire Systems facilitate placement and exchange of catheters and other instruments in the peripheral vasculature. The ZigiWire Guidewire Systems are not intended for use in the coronary arteries or neurovasculature.

Source page: https://510kreport.com/device/K141218
Methodology: https://510kreport.com/methodology