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

About This 510(k) Submission

K220008 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 HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, 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 June 2, 2022, 149 days after receiving the submission on January 4, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.5900.