THE OMNIGUIDE GUIDING CATHETER WITH BALLOON

THE OMNIGUIDE GUIDING CATHETER WITH BALLOON is an FDA 510(k)-cleared medical device (K945963) manufactured by Micro Interventional Systems, 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 7, 1995. Regulation: 8.