PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)

PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) is an FDA 510(k)-cleared medical device (K991404) manufactured by Itl Corporation Pty, Ltd.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 13, 1999. Regulation: 8.