transGlide Expandable Introducer

transGlide Expandable Introducer is an FDA 510(k)-cleared medical device (K152194) manufactured by Transaortic Medical, 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 April 6, 2016. Regulation: 8.