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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 K192125
Device Name Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
AtriCure, Inc
7555 Innovation Way
mason,  OH  45040
Applicant Contact johnathon mcelwee
AtriCure, Inc
7555 Innovation Way
mason,  OH  45040
Correspondent Contact kristen evenson
Regulation Number878.4400
Classification Product Code
Date Received08/06/2019
Decision Date 11/04/2019
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