510(k) K081997

PERFADEX WITH THAM by Vitrolife Sweden AB — Product Code MSB

K081997 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "PERFADEX WITH THAM". The FDA issued a decision of Substantially Equivalent on October 9, 2008. The device falls under product code MSB (System And Accessories, Isolated Heart, Transport And Preservation), a Class II device regulated under 21 CFR 876.5880. Vitrolife Sweden AB has at least 10 other 510(k) clearances on record.