Cleared Special

ArtiClip LAA Exclusion System

K181474 · AtriCure, Inc. · Cardiovascular
Jun 2018
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K181474 is an FDA 510(k) clearance for the ArtiClip 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 June 28, 2018, 24 days after receiving the submission on June 4, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K181474 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2018
Decision Date June 28, 2018
Days to Decision 24 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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