CAPIOX SX HARDSHELL RESERVOIR

CAPIOX SX HARDSHELL RESERVOIR is an FDA 510(k)-cleared medical device (K980935) 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 May 13, 1998. Regulation: 8.