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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophageal Thermal Regulation And Gastric Suctioning Device
510(k) Number K250632
Device Name Arctx Cool Catheter Set
Applicant
Arctx Medical
5856 Farington Pl., Suite 200
Raleigh,  NC  27609
Applicant Contact Don Gurskis
Correspondent
Domecus Consulting Services, LLC
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number870.5910
Classification Product Code
PLA  
Date Received03/03/2025
Decision Date 10/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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