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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 K153226
Device Name Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
Applicant
Zoll Circulation, Inc.
2000 Ringwood Ave.
San Jose,  CA  95131
Applicant Contact SAM NANAVATI
Correspondent
Zoll Circulation, Inc.
2000 Ringwood Ave.
San Jose,  CA  95131
Correspondent Contact SAM NANAVATI
Regulation Number870.5900
Classification Product Code
NCX  
Date Received11/06/2015
Decision Date 03/24/2016
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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