510(k) K101987

COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 by Zoll Circulation — Product Code NCX

K101987 is an FDA 510(k) premarket notification submitted by Zoll Circulation for the device "COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593". The FDA issued a decision of SESU on October 12, 2010. The device falls under product code NCX (System, Hypothermia, Intravenous, Cooling), a Class II device regulated under 21 CFR 870.5900. Zoll Circulation has at least 10 other 510(k) clearances on record.