510(k) K130359

CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA by Terumo Cardiovascular Systems Corp. — Product Code DTZ

K130359 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corp. for the device "CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA". The FDA issued a decision of Substantially Equivalent on March 13, 2013. 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.