NC Quantum Apex PTCA Dilatation Catheter

NC Quantum Apex PTCA Dilatation Catheter is an FDA 510(k)-cleared medical device (K160823) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 2016. Regulation: 8.