0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE

0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE is an FDA 510(k)-cleared medical device (K000632) manufactured by Avitro, LLC. 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 October 18, 2000. Regulation: 8.