EXTesia Introducer Sheath Set

EXTesia Introducer Sheath Set is an FDA 510(k)-cleared medical device (K220604) manufactured by Curatia Medical Co.. 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 26, 2022. Regulation: 8.