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FDA 510(k) Application Details - K221358
Device Classification Name
Surgical Device, For Ablation Of Cardiac Tissue
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510(K) Number
K221358
Device Name
Surgical Device, For Ablation Of Cardiac Tissue
Applicant
AtriCure, Inc
7555 Innovation Way
Mason, OH 45040 US
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Contact
Jonathan McElwee
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
OCL
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More FDA Info for this Product Code
Date Received
05/11/2022
Decision Date
12/30/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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