510(k) K872133

OXYGENATOR MODEL NO. BENTLEY 5 PLUS by American Bentley — Product Code DTZ

K872133 is an FDA 510(k) premarket notification submitted by American Bentley for the device "OXYGENATOR MODEL NO. BENTLEY 5 PLUS". The FDA issued a decision of Substantially Equivalent on August 24, 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.