Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console

About This 510(k) Submission

K223746 is an FDA 510(k) clearance for the Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console, 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 January 13, 2023, 30 days after receiving the submission on December 14, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.5900.