AcuNav Diagnostic Ultrasound Catheter 8F,10F

AcuNav Diagnostic Ultrasound Catheter 8F,10F is an FDA 510(k)-cleared medical device (K170263) 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 June 14, 2017. Regulation: 8.