510(k) K931444

PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS by Sorin Biomedica, Fiat, USA, Inc. — Product Code DTZ

K931444 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS". The FDA issued a decision of Substantially Equivalent on May 27, 1994. 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.