# K242229: Micro Ace Gold Advanced Micro Access System

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jan 15, 2025 after 169 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: 2 generations back to K031691 (2003). 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)
- K232609: Micro Ace™ Advanced Micro Access System, Merit Medical Systems, Inc. (2023) Summary page 5.

## Indications for use
The Merit Micro Ace™ Gold Advanced Micro Access System is intended for percutaneous placement of a 0.035” (0.89mm) or 0.038” (0.97mm) guidewire into the vascular system.

Source page: https://510kreport.com/device/K242229
Methodology: https://510kreport.com/methodology