510(k) K213031

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 by Zoll Circulation, Inc. — Product Code NCX

K213031 is an FDA 510(k) premarket notification submitted by Zoll Circulation, Inc. for the device "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". The FDA issued a decision of SESU on December 20, 2021. The device falls under product code NCX (System, Hypothermia, Intravenous, Cooling), a Class II device regulated under 21 CFR 870.5900. Zoll Circulation, Inc. has at least 10 other 510(k) clearances on record.