SOLITAIRE FR REVASCULARIZATION DEVICE

SOLITAIRE FR REVASCULARIZATION DEVICE is an FDA 510(k)-cleared medical device (K113455) manufactured by Micro Therapeutics Dba 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 March 1, 2012. Regulation: 8.