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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 K070161
Device Name QUATTRO CATHETER MODEL IC4593
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 Received01/17/2007
Decision Date 02/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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