AcQCross Qx Integrated Transseptal Dilator/Needle

AcQCross Qx Integrated Transseptal Dilator/Needle is an FDA 510(k)-cleared medical device (K210685) 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 April 5, 2021. Regulation: 8.