Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Hypothermia, Intravenous, Cooling
510(k) Number K060308
Device Name COOLGARD 3000
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
Correspondent Contact KENNETH A COLLINS
Regulation Number870.5900
Classification Product Code
NCX  
Date Received02/07/2006
Decision Date 04/26/2006
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-