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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 K150046
Device Name Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
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 Received01/12/2015
Decision Date 10/30/2015
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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