510(k) K233904

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ by Acist Medical Systems, Inc. — Product Code DXO

K233904 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "ACIST RXi System (016616); ACIST Navvus II Catheter (016675_". The FDA issued a decision of Substantially Equivalent on July 17, 2024. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Acist Medical Systems, Inc. has at least 10 other 510(k) clearances on record.