CAPIOX BUBBLE TRAP WITH X-COATING

CAPIOX BUBBLE TRAP WITH X-COATING is an FDA 510(k)-cleared medical device (K090698) manufactured by Terumo Cardiovascular Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2009. Regulation: 8.