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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K261437
Device Name Mistral-Air® Warming System
Applicant
The Surgical Company International B.V., doing business as TSC Life
Paalbergweg 3
Noord-Holland
Amsterdam,  NL 1105 AG
Applicant Contact Gianpaolo Soares
Correspondent
The Surgical Company International B.V., doing business as TSC Life
Paalbergweg 3
Noord-Holland
Amsterdam,  NL 1105 AG
Correspondent Contact Gianpaolo Soares
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received04/30/2026
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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