510(k) K030264

QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 by Jostra AG — Product Code DTZ

K030264 is an FDA 510(k) premarket notification submitted by Jostra AG for the device "QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030". The FDA issued a decision of Substantially Equivalent on February 26, 2003. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Jostra AG has at least 10 other 510(k) clearances on record.