510(k) K091989

PERFADEX AND PERFADEX WITH THAM by Xvivo Perfusion AB — Product Code KDN

K091989 is an FDA 510(k) premarket notification submitted by Xvivo Perfusion AB for the device "PERFADEX AND PERFADEX WITH THAM". The FDA issued a decision of Substantially Equivalent on October 1, 2010. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Xvivo Perfusion AB has at least 2 other 510(k) clearances on record.