Abiomed 14Fr Low Profile Introducer Set

Abiomed 14Fr Low Profile Introducer Set is an FDA 510(k)-cleared medical device (K222113) manufactured by Abiomed, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 12, 2022. Regulation: 8.