transGlideXT Expandable Introducer

transGlideXT Expandable Introducer is an FDA 510(k)-cleared medical device (K181817) 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 March 25, 2019. Regulation: 8.