510(k) K153140

Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating by Terumo Cardiovascular Systems Corp. — Product Code DTZ

K153140 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corp. for the device "Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating". The FDA issued a decision of Substantially Equivalent on December 2, 2015. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Terumo Cardiovascular Systems Corp. has at least 10 other 510(k) clearances on record.