AcQGuide MAX Steerable Sheath

AcQGuide MAX Steerable Sheath is an FDA 510(k)-cleared medical device (K211100) manufactured by Acutus Medical, 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 May 13, 2021. Regulation: 8.