Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)

Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) is an FDA 510(k)-cleared medical device (K193576) 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 19, 2020. Regulation: 8.