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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 K101174
Device Name ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
Applicant
AtriCure, Inc.
6217 Center Park Dr.
West Chester,  OH  45069
Applicant Contact JAMES LUCKY
Correspondent
AtriCure, Inc.
6217 Center Park Dr.
West Chester,  OH  45069
Correspondent Contact JAMES LUCKY
Regulation Number878.4400
Classification Product Code
OCL  
Date Received04/27/2010
Decision Date 11/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00560885
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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