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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 9 of 9 Results
ProductCode: NCX Applicant: ALSIUS CORP Decision Date To: 04/17/2014
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solex catheter, model sl2593 ALSIUS CORP. K081936 08/13/2008
thermogard xp thermal regulation system ALSIUS CORP. K072234 08/23/2007
quattro catheter model ic4593 ALSIUS CORP. K070161 02/15/2007
thermogard thermal regulation system ALSIUS CORP. K063829 01/22/2007
coolgard 3000 ALSIUS CORP. K060308 04/26/2006
icy catheter, model ic-3893a ALSIUS CORP. K052443 10/17/2005
cool line catheter kit, models cl-2085b, cl-2295a; icy catheter kit, model ic-3585a; fortius catheter kit, mod. fr-5093b ALSIUS CORP. K051912 10/11/2005
alsius coolgard 3000 & alsius catheter system ALSIUS CORP. K030421 10/23/2003
coolgard 3000, cooline, start-up, models 3000, cl-2085b, cl-2295a, cg-500d ALSIUS CORP. K014241 08/01/2003
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