MEDCOMP VASCU-SHEATH INTRODUCER SET

MEDCOMP VASCU-SHEATH INTRODUCER SET is an FDA 510(k)-cleared medical device (K022513) manufactured by Medcomp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2002. Regulation: 8.