AMPLATZER TorqVue 45x45 Delivery Sheath

AMPLATZER TorqVue 45x45 Delivery Sheath is an FDA 510(k)-cleared medical device (K163000) manufactured by Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 2016. Regulation: 8.