Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

About This 510(k) Submission

K213031 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, Start-Up Kit, Coolgard 3000 Console, Thermogard XP 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 December 20, 2021, 90 days after receiving the submission on September 21, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.5900.