MEDCOMP VASCU-SHEATH II

MEDCOMP VASCU-SHEATH II is an FDA 510(k)-cleared medical device (K053092) 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 July 31, 2006. Regulation: 8.