VALVED TEARAWAY INTRODUCER GENERATION II

VALVED TEARAWAY INTRODUCER GENERATION II is an FDA 510(k)-cleared medical device (K124046) manufactured by Medical Components, Inc.. 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 2, 2013. Regulation: 8.