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 K051912
Device Name COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B
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 Received07/14/2005
Decision Date 10/11/2005
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
Predetermined Change
Control Plan Authorized		 No
-
-