510(k) K022391

MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION by Organ Recovery Systems, Inc. — Product Code KDN

K022391 is an FDA 510(k) premarket notification submitted by Organ Recovery Systems, Inc. for the device "MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION". The FDA issued a decision of Substantially Equivalent on October 21, 2002. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Organ Recovery Systems, Inc. has at least 3 other 510(k) clearances on record.