SUPER SHEATH INTRODUCER SHEATH

SUPER SHEATH INTRODUCER SHEATH is an FDA 510(k)-cleared medical device (K052557) manufactured by Togo Medikit Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2006. Regulation: 8.