Cleared Special

Micro Ace? Advanced Micro Access System

K232609 · Merit Medical Systems, Inc. · Cardiovascular
Sep 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K232609 is an FDA 510(k) clearance for the Micro Ace? 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 September 27, 2023, 30 days after receiving the submission on August 28, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number K232609 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2023
Decision Date September 27, 2023
Days to Decision 30 days
Submission Type Special
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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