14F iSLEEVE Introducer Set

14F iSLEEVE Introducer Set is an FDA 510(k)-cleared medical device (K233503) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 29, 2023. Regulation: 8.