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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
510(k) Number K210477
Device Name AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
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 Number878.4400
Classification Product Code
Date Received02/19/2021
Decision Date 07/26/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No