
Togo Medikit Co., Ltd.
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SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS is an FDA 510(k)-cleared medical device (K121504) 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 September 26, 2012. Regulation: 8.