510(k) K130333

CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR by Terumo Cardiovascular Systems Corp. — Product Code DTZ

K130333 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corp. for the device "CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR". 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.