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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 K172742
Device Name AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Applicant Contact Melissa Smallwood
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Correspondent Contact Melissa Smallwood
Regulation Number878.4300
Classification Product Code
Date Received09/12/2017
Decision Date 10/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No