TorqVue Low Profile Delivery Catheter

TorqVue Low Profile Delivery Catheter is an FDA 510(k)-cleared medical device (K162228) manufactured by Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor. 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 8, 2016. Regulation: 8.