EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER

EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER is an FDA 510(k)-cleared medical device (K872719) 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 September 29, 1987. Regulation: 8.