510(k) K022730

PERFADEX SOLUTION FOR LUNG PRESERVATION by Vitrolife AB — Product Code MSB

K022730 is an FDA 510(k) premarket notification submitted by Vitrolife AB for the device "PERFADEX SOLUTION FOR LUNG PRESERVATION". The FDA issued a decision of Substantially Equivalent on October 27, 2003. 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 AB has at least 8 other 510(k) clearances on record.