Peel-Away Introducer Sheath

Peel-Away Introducer Sheath is an FDA 510(k)-cleared medical device (K254236) manufactured by VascuTech Medical, 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 February 8, 2026. Regulation: 8.