CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath is an FDA 510(k)-cleared medical device (K170997) manufactured by Biosense Webster, 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 24, 2017. Regulation: 8.