AMPLATZER TORQ VUE LP DELIVERY SYSTEM

AMPLATZER TORQ VUE LP DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K131063) manufactured by St Jude 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 August 14, 2013. Regulation: 8.