FDA 510(k) Application Details - K211311

Device Classification Name Surgical Device, For Ablation Of Cardiac Tissue

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510(K) Number K211311
Device Name Surgical Device, For Ablation Of Cardiac Tissue
Applicant AtriCure, Inc.
7555 Innovation Way
Mason, OH 45040 US
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Contact Jon McElwee
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Regulation Number 878.4400

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Classification Product Code OCL
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Date Received 04/30/2021
Decision Date 05/28/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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