BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX

BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX is an FDA 510(k)-cleared medical device (K032292) manufactured by Bioteque Corp.. 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 March 21, 2004. Regulation: 8.