Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires is an FDA 510(k)-cleared medical device (K191173) manufactured by Abbott Vascular. 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, 2019. Regulation: 8.