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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 K081936
Device Name SOLEX CATHETER, MODEL SL2593
Original Applicant
ALSIUS CORP.
15770 laguna canyon, suite 150
irvine,  CA  92618
Original Contact john riolo
Regulation Number870.5900
Classification Product Code
NCX  
Date Received07/07/2008
Decision Date 08/13/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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