Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters is an FDA 510(k)-cleared medical device (K161596) 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 April 27, 2017. Regulation: 8.