Solitaire Platinum Revascularization Device, 6x40 mm

Solitaire Platinum Revascularization Device, 6x40 mm is an FDA 510(k)-cleared medical device (K160641) manufactured by Micro Therapeutics, Inc. d/b/a 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 7, 2017. Regulation: 8.