VANES Delivery System (VDS)

VANES Delivery System (VDS) is an FDA 510(k)-cleared medical device (K260459) manufactured by Zoll Respicardia, 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 April 5, 2026. Regulation: 8.