ACIST RXi System (016616); ACIST Navvus II Catheter (016675_

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ is an FDA 510(k)-cleared medical device (K233904) manufactured by Acist Medical Systems, 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 July 16, 2024. Regulation: 8.