Alsius Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Alsius Corp. - FDA 510(k) Cleared Devices
9
Total
5
Cleared
0
Denied
Alsius Corp. has 5 FDA 510(k) cleared medical devices. Based in Irvine, US.
Historical record: 5 cleared submissions from 2003 to 2008. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Alsius Corp. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Alsius Corp.
9 devices
Cleared
Aug 13, 2008
SOLEX CATHETER, MODEL SL2593
Neurology
37d
Cleared
Aug 23, 2007
THERMOGARD XP THERMAL REGULATION SYSTEM
Neurology
13d
Cleared
Feb 15, 2007
QUATTRO CATHETER MODEL IC4593
Neurology
29d
Cleared
Jan 22, 2007
THERMOGARD THERMAL REGULATION SYSTEM
Neurology
27d
Cleared
Apr 26, 2006
COOLGARD 3000
Neurology
78d
Cleared
Oct 17, 2005
ICY CATHETER, MODEL IC-3893A
Neurology
41d
Cleared
Oct 11, 2005
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A
Neurology
89d
Cleared
Oct 23, 2003
ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
Neurology
255d
Cleared
Aug 01, 2003
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
Neurology
583d