Amplatzer Steerable Delivery Sheath

Amplatzer Steerable Delivery Sheath is an FDA 510(k)-cleared medical device (K220340) 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 March 8, 2022. Regulation: 8.