SafeCross Vascular Introducer System (4001)

SafeCross Vascular Introducer System (4001) is an FDA 510(k)-cleared medical device (K240600) manufactured by East End Medical I, 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 September 5, 2024. Regulation: 8.