Genie MAX Large Bore Introducer Sheath

Genie MAX Large Bore Introducer Sheath is an FDA 510(k)-cleared medical device (K253652) manufactured by Cultiv8 1, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 2026. Regulation: 8.