LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) is an FDA 510(k)-cleared medical device (K021362) manufactured by Organ Recovery Systems, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 30, 2003. Regulation: 8.