EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET

EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET is an FDA 510(k)-cleared medical device (K980504) manufactured by Schneider/Namic. 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 6, 1998. Regulation: 8.