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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K163261
Device Name AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
Applicant
AtriCure, Inc.
7555 Innovation Way
West Chester,  OH  45040
Applicant Contact Jonathan McElwee
Correspondent
AtriCure, Inc.
7555 Innovation Way
West Chester,  OH  45040
Correspondent Contact Jonathan McElwee
Regulation Number878.4300
Classification Product Code
FZP  
Date Received11/21/2016
Decision Date 05/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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