510(k) K873923

INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER by American Bentley — Product Code DTZ

K873923 is an FDA 510(k) premarket notification submitted by American Bentley for the device "INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER". The FDA issued a decision of Substantially Equivalent on November 6, 1987. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. American Bentley has at least 10 other 510(k) clearances on record.