510(k) K022115

CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR by Terumo Corp. — Product Code DTZ

K022115 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR". The FDA issued a decision of Substantially Equivalent on September 27, 2002. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Terumo Corp. has at least 10 other 510(k) clearances on record.