CAPIOX SX10 HARDSHELL RESEVOIR

CAPIOX SX10 HARDSHELL RESEVOIR is an FDA 510(k)-cleared medical device (K991973) 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 September 2, 1999. Regulation: 8.