# K193571: Go2Wire Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical System, Inc.
- Decided: Apr 8, 2020 after 107 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 K861765 (1986). 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)
- K120863: Wholey Guide Wire System, Covidien, LLC (2012) Summary page 4.

## Indications for use
The Merit G02\1ffiETV is intended to facilitate the placement md exchange of devices during peripheral diagnostic and interventional procedures. Carefully read all instructions prior to use. Observe all warnings and cautions noted throughout these instructions. failure lo J.o w way 1«::sull iu wuaplic.:aliows.

Source page: https://510kreport.com/device/K193571
Methodology: https://510kreport.com/methodology