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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hypothermia, Intravenous, Cooling
510(k) Number K223746
Device Name Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
Applicant
Zoll Circulation, Inc.
2000 Ringwood Ave.
San Jose,  CA  95131
Applicant Contact Brian Robey
Correspondent
Zoll Circulation, Inc.
2000 Ringwood Ave.
San Jose,  CA  95131
Correspondent Contact Brian Robey
Regulation Number870.5900
Classification Product Code
NCX  
Date Received12/14/2022
Decision Date 01/13/2023
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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