# K091584: Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 9, 2009 after 129 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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 1.

## Most influential descendants
- K130730: V-Stick Vascular Access Set (2013), 1 descendant of its own
- K253741: V•Stick™ Vascular Access Set (2025), 0 descendants of its own

## Indications for use
The Merit MAK® (Mini Access Kit) is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.

Source page: https://510kreport.com/device/K091584
Methodology: https://510kreport.com/methodology