510(k) K150046

Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter by Zoll Circulation, Inc. — Product Code NCX

K150046 is an FDA 510(k) premarket notification submitted by Zoll Circulation, Inc. for the device "Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter". The FDA issued a decision of SESU on October 30, 2015. 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.