Solitaire 4 Revascularization Device

Solitaire 4 Revascularization Device is an FDA 510(k)-cleared medical device (K183022) 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 January 28, 2019. Regulation: 8.