Cleared Special

AtriClip LAA Exclusion System

K210293 · AtriCure, Inc. · Cardiovascular
Mar 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K210293 is an FDA 510(k) clearance for the AtriClip LAA Exclusion System, 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 March 3, 2021, 29 days after receiving the submission on February 2, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K210293 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2021
Decision Date March 03, 2021
Days to Decision 29 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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