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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
Applicant
Alsius Corp.
15770 Laguna Canyon, Suite 150
Irvine,  CA  92618
Applicant Contact JOHN RIOLO
Correspondent
Alsius Corp.
15770 Laguna Canyon, Suite 150
Irvine,  CA  92618
Correspondent Contact JOHN RIOLO
Regulation Number870.5900
Classification Product Code
NCX  
Date Received07/07/2008
Decision Date 08/13/2008
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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