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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Left Atrial Appendage Clip, Implantable
510(k) Number K210293
Device Name AtriClip LAA Exclusion System
Applicant
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Applicant Contact Mary Galeano
Correspondent
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Correspondent Contact Mary Galeano
Regulation Number878.4300
Classification Product Code
PZX  
Date Received02/02/2021
Decision Date 03/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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