# K261640: Merit MAK Nitinol/Gold-Tungsten Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Ireland, Ltd.
- Decided: Jul 13, 2026 after 56 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: 1 generation back to K031691 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031691: Merit Mak (Mini Access Kit), Merit Medical Systems, Inc. (2003) Summary page 5.

## Indications for use
The Merit MAK is intended for percutaneous placement of a 0.035” (0.89mm) or 0.038” (0.97mm) guide wire into the vascular and non-vascular system. This device is not intended for use in the coronary vasculature or neurovasculature.

Source page: https://510kreport.com/device/K261640
Methodology: https://510kreport.com/methodology