ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM


Device Classification Name

system, hypothermia, intravenous, cooling

510(k) Number K030421
Device Name ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
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

Correspodent Contact kenneth a collins
Regulation Number 870.5900
Classification Product Code
NCX  
Date Received 02/10/2003
Decision Date 10/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls