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 K101987
Device Name COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
Applicant
Zoll Circulation
650 Almanor Ave.
Sunnyvale,  CA  94085
Applicant Contact SAM NANAVATI
Correspondent
Zoll Circulation
650 Almanor Ave.
Sunnyvale,  CA  94085
Correspondent Contact SAM NANAVATI
Regulation Number870.5900
Classification Product Code
NCX  
Date Received07/14/2010
Decision Date 10/12/2010
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
-
-