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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Surgical, Cryogenic
510(k) Number K250371
Device Name cryoICE cryoXT cryoablation probe (cryoXT)
Applicant
AtriCure, Inc.
7555 Innovation Way
West Chester,  OH  45040
Applicant Contact Ronit Shah
Correspondent
AtriCure, Inc.
7555 Innovation Way
West Chester,  OH  45040
Correspondent Contact Ronit Shah
Regulation Number882.4250
Classification Product Code
GXH  
Date Received02/10/2025
Decision Date 04/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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