StrataMR II Valves and Shunts

StrataMR II Valves and Shunts is an FDA 510(k)-cleared medical device (K212641) manufactured by Medtronic Neurosurgery. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 15, 2021. Regulation: 8.