Medical Device Manufacturer · US , Irvine , CA

Alsius Corp. - FDA 510(k) Cleared Devices

9 submissions · 5 cleared · Since 2003

Recent clearances: SOLEX CATHETER, MODEL SL2593, THERMOGARD XP THERMAL REGULATION SYSTEM, QUATTRO CATHETER MODEL IC4593

View 9 510(k) Devices ↓

9

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Alsius Corp. Neurology ✕

9 devices

1-9 of 9

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

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