Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter

About This 510(k) Submission

K150046 is an FDA 510(k) clearance for the Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, a System, Hypothermia, Intravenous, Cooling (Class II — Special Controls, product code NCX), submitted by Zoll Circulation, Inc. (San Jose, US). The FDA issued a Cleared decision on October 30, 2015, 291 days after receiving the submission on January 12, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 870.5900.