MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE

MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE is an FDA 510(k)-cleared medical device (K860449) manufactured by Top Corp.. 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 February 25, 1986. Regulation: 8.