Mini Stick ENVI Non-Vascular Introducer Kit

Mini Stick ENVI Non-Vascular Introducer Kit is an FDA 510(k)-cleared medical device (K170775) manufactured by AngioDynamics, 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 July 18, 2017. Regulation: 8.