510(k) K875095

PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE by Pall Biomedical Products Co. — Product Code JOD

K875095 is an FDA 510(k) premarket notification submitted by Pall Biomedical Products Co. for the device "PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE". The FDA issued a decision of Substantially Equivalent on February 29, 1988. The device falls under product code JOD (Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4270. Pall Biomedical Products Co. has at least 10 other 510(k) clearances on record.