Artix Ballon Guiding Sheath

Artix Ballon Guiding Sheath is an FDA 510(k)-cleared medical device (K221846) manufactured by Inari Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 10, 2022. Regulation: 8.