SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL

SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL is an FDA 510(k)-cleared medical device (K852070) manufactured by Shiley, Inc.. 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 June 12, 1985. Regulation: 8.