510(k) K922933

SORIN MONOLYRH INTEGRATED MEMBRANE LUNG by Sorin Biomedica, Fiat, USA, Inc. — Product Code DTZ

K922933 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "SORIN MONOLYRH INTEGRATED MEMBRANE LUNG". The FDA issued a decision of Substantially Equivalent on November 30, 1992. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.