A.V. FISTULA NEEDLE

A.V. FISTULA NEEDLE is an FDA 510(k)-cleared medical device (K001496) manufactured by Exelint International, Co.. 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 31, 2000. Regulation: 8.