AcuNav Crystal Ultrasound Catheter

AcuNav Crystal Ultrasound Catheter is an FDA 510(k)-cleared medical device (K233270) manufactured by Siemens Medical Solutions USA, 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 October 27, 2023. Regulation: 8.