Abiomed 23 Fr Sheath

Abiomed 23 Fr Sheath is an FDA 510(k)-cleared medical device (K201116) 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 June 14, 2020. Regulation: 8.