BONCHEK-SHILEY VEIN DISTENTION SYSTEM

BONCHEK-SHILEY VEIN DISTENTION SYSTEM is an FDA 510(k)-cleared medical device (K792134) manufactured by Shiley, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 3, 1979. Regulation: 8.