Medtronic Confida Brecker Guidewire

Medtronic Confida Brecker Guidewire is an FDA 510(k)-cleared medical device (K150465) manufactured by Medtronic Core Valve, LLC. 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 2, 2015. Regulation: 8.