10F Sheath and Dilator Set

10F Sheath and Dilator Set is an FDA 510(k)-cleared medical device (K233432) manufactured by Argon Medical Devices, 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 December 7, 2023. Regulation: 8.