# K232609: Micro Ace™ Advanced Micro Access System

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Sep 27, 2023 after 30 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 4.

## Most influential descendants
- K242229: Micro Ace Gold Advanced Micro Access System (2025), 0 descendants of its own

## Indications for use
The Micro Ace™ 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/K232609
Methodology: https://510kreport.com/methodology