510(k) K870804

CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 by American Bentley — Product Code DTR

K870804 is an FDA 510(k) premarket notification submitted by American Bentley for the device "CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100". The FDA issued a decision of Substantially Equivalent on September 1, 1987. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. American Bentley has at least 10 other 510(k) clearances on record.