CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING

CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING is an FDA 510(k)-cleared medical device (K002238) manufactured by Terumo Cardiovascular Systems 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 August 21, 2000. Regulation: 8.