510(k) K925369

BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS by Sorin Biomedica, Fiat, USA, Inc. — Product Code DTR

K925369 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS". The FDA issued a decision of Substantially Equivalent on March 26, 1993. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.