510(k) K875094

ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE by Pall Biomedical Products Co. — Product Code KRJ

K875094 is an FDA 510(k) premarket notification submitted by Pall Biomedical Products Co. for the device "ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE". The FDA issued a decision of Substantially Equivalent on Feb 29, 1988. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. Pall Biomedical Products Co. has 27 other 510(k) clearances on record.