Solitaire 2 Revascularization Device

Solitaire 2 Revascularization Device is an FDA 510(k)-cleared medical device (K162539) manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 9, 2016. Regulation: 8.