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 K220008
Device Name Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
Applicant
ZOLL Circulation, Inc
2000 Ringwood Avenue
San Jose,  CA  95131
Applicant Contact Elizabeth Haines
Correspondent
ZOLL Circulation, Inc
2000 Ringwood Avenue
San Jose,  CA  95131
Correspondent Contact Elizabeth Haines
Regulation Number870.5900
Classification Product Code
NCX  
Date Received01/04/2022
Decision Date 06/02/2022
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
-
-