PHOENIX HEMODIALYSIS DELIVERY SYSTEM

PHOENIX HEMODIALYSIS DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K103832) manufactured by Gambro Renal Products, 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 May 19, 2011. Regulation: 8.