Cleared Special

AtriClip PRO-Mini LAA Exclusion System (PROM)

K243860 · AtriCure, Inc. · Cardiovascular
Jan 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K243860 is an FDA 510(k) clearance for the AtriClip PRO-Mini LAA Exclusion System (PROM), 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 January 15, 2025, 30 days after receiving the submission on December 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K243860 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2024
Decision Date January 15, 2025
Days to Decision 30 days
Submission Type Special
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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