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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 K052443
Device Name ICY CATHETER, MODEL IC-3893A
Applicant
Alsius Corp.
15770 Laguna Canyon, Suite 150
Irvine,  CA  92618
Applicant Contact KENNETH A COLLINS
Correspondent
Alsius Corp.
15770 Laguna Canyon, Suite 150
Irvine,  CA  92618
Correspondent Contact KENNETH A COLLINS
Regulation Number870.5900
Classification Product Code
NCX  
Date Received09/06/2005
Decision Date 10/17/2005
Decision Substantially Equivalent (SESE)
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
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