GOPHER GOLD CATHETER, MODEL 5620

GOPHER GOLD CATHETER, MODEL 5620 is an FDA 510(k)-cleared medical device (K091345) manufactured by Vascular Solutions, 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 June 11, 2009. Regulation: 8.