15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set

15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set is an FDA 510(k)-cleared medical device (K191871) 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 August 6, 2019. Regulation: 8.