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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 K233357
Device Name EsoCool Thermal Regulation Catheter
Applicant
Nuvaira, Inc.
6500 Wedgewood N., Suite 100
Maple Grove,,  MN  55311
Applicant Contact John Carline
Correspondent
Nuvaira, Inc.
6500 Wedgewood N., Suite 100
Maple Grove,,  MN  55311
Correspondent Contact John Carline
Regulation Number870.5910
Classification Product Code
PLA  
Date Received09/29/2023
Decision Date 06/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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