5F ENVOY(TM) GUIDING CATHETER

5F ENVOY(TM) GUIDING CATHETER is an FDA 510(k)-cleared medical device (K945705) manufactured by Cordis Neurovascular, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 1995. Regulation: 8.