PTFE Super Sheath Introducer 2.1

PTFE Super Sheath Introducer 2.1 is an FDA 510(k)-cleared medical device (K153246) manufactured by Medcomp (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 February 11, 2016. Regulation: 8.