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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 K051912
Device Name COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B
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 Received07/14/2005
Decision Date 10/11/2005
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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