Reprocessed Carto Vizigo Bi-Directional Guiding Sheath

Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is an FDA 510(k)-cleared medical device (K212165) manufactured by Innovative Health, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 9, 2022. Regulation: 8.