Cleared Traditional

AtriClip FLEX-Mini LAA Exclusion System (ACHM)

K234125 · AtriCure, Inc. · Cardiovascular
Jul 2024
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K234125 is an FDA 510(k) clearance for the AtriClip FLEX-Mini LAA Exclusion System (ACHM), a Left Atrial Appendage Clip, Implantable (Class II — Special Controls, product code PZX), submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on July 29, 2024, 214 days after receiving the submission on December 28, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K234125 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2023
Decision Date July 29, 2024
Days to Decision 214 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code PZX — Left Atrial Appendage Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300
Definition Intended To Occlude The Left Atrial Appendage.

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