510(k) K860673

OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B by American Bentley — Product Code DTZ

K860673 is an FDA 510(k) premarket notification submitted by American Bentley for the device "OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B". The FDA issued a decision of Substantially Equivalent on June 26, 1986. 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.