510(k) K000255

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

K000255 is an FDA 510(k) premarket notification submitted by Cobe Cardiovascular, Inc. for the device "COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR". The FDA issued a decision of Substantially Equivalent on April 25, 2000. 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.