510(k) K013480

COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR by Cobe Cardiovascular, Inc. — Product Code DTZ

K013480 is an FDA 510(k) premarket notification submitted by Cobe Cardiovascular, Inc. for the device "COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR". The FDA issued a decision of Substantially Equivalent on November 16, 2001. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Cobe Cardiovascular, Inc. has at least 10 other 510(k) clearances on record.