Amplatzer Talisman Delivery Sheath

Amplatzer Talisman Delivery Sheath is an FDA 510(k)-cleared medical device (K212738) manufactured by ABBOTT MEDICAL. 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 26, 2021. Regulation: 8.