CAPIOX HARDSHELL VENOUS RESERVOIR

CAPIOX HARDSHELL VENOUS RESERVOIR is an FDA 510(k)-cleared medical device (K894664) manufactured by Terumo Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 1990. Regulation: 8.