Solitaire 2 and Solitaire Platinum Revascularization Device

Solitaire 2 and Solitaire Platinum Revascularization Device is an FDA 510(k)-cleared medical device (K181060) manufactured by Medtronic 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 August 23, 2018. Regulation: 8.