MEDTRONIC (R) MODEL 3625 SCREENER

MEDTRONIC (R) MODEL 3625 SCREENER is an FDA 510(k)-cleared medical device (K903690) manufactured by Medtronic Vascular. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 1991. Regulation: 8.