Cleared Traditional

Micro Ace Gold Advanced Micro Access System

K242229 · Merit Medical Systems, Inc. · Cardiovascular
Jan 2025
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K242229 is an FDA 510(k) clearance for the Micro Ace Gold Advanced Micro Access System, a Dilator, Vessel, For Percutaneous Catheterization (Class II — Special Controls, product code DRE), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 15, 2025, 169 days after receiving the submission on July 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number K242229 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2024
Decision Date January 15, 2025
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRE — Dilator, Vessel, For Percutaneous Catheterization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1310

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