|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
solex catheter, model sl2593
|
ALSIUS CORP.
|
K081936 |
08/13/2008
|
quattro catheter model ic4593
|
ALSIUS CORP.
|
K070161 |
02/15/2007
|
thermogard xp thermal regulation system
|
ALSIUS CORP.
|
K072234 |
08/23/2007
|
coolgard 3000
|
ALSIUS CORP.
|
K060308 |
04/26/2006
|
thermogard thermal regulation system
|
ALSIUS CORP.
|
K063829 |
01/22/2007
|
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
|
icy catheter, model ic-3893a
|
ALSIUS CORP.
|
K052443 |
10/17/2005
|
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
|