ArtiClip LAA Exclusion System

Left Atrial Appendage Clip, Implantable

AtriCure, Inc.

The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Articlip Laa Exclusion System.

Pre-market Notification Details

Device IDK181474
510k NumberK181474
Device Name:ArtiClip LAA Exclusion System
ClassificationLeft Atrial Appendage Clip, Implantable
Applicant AtriCure, Inc. 7555 Innovation Way Mason,  OH  45040
ContactJonathan Mcelwee
CorrespondentJonathan Mcelwee
AtriCure, Inc. 7555 Innovation Way Mason,  OH  45040
Product CodePZX  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-04
Decision Date2018-06-28
Summary:summary

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