Concerto Versa, Detachable Coil

Concerto Versa, Detachable Coil is an FDA 510(k)-cleared medical device (K202850) manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 8, 2021. Regulation: 8.