510(k) K861641

HEPARIN-COATED EXTRACORPOREAL CIRCUITS by American Bentley — Product Code DTZ

K861641 is an FDA 510(k) premarket notification submitted by American Bentley for the device "HEPARIN-COATED EXTRACORPOREAL CIRCUITS". The FDA issued a decision of Substantially Equivalent on September 29, 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.