# K230418: Mighty Wire Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 28, 2023 after 254 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: 3 generations back to K061670 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220137: Lunderquist Extra Stiff Wire Guide, William Cook Europe Aps (2022) Summary page 4.

## Indications for use
The Merit Mighty Wire is intended to be used to facilitate the placement of devices during diagnostic and interventional procedures in the central circulatory system, excluding the coronary arteries and neurovasculature.

Source page: https://510kreport.com/device/K230418
Methodology: https://510kreport.com/methodology