# K233904: ACIST RXi System (016616); ACIST Navvus II Catheter (016675_

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems, Inc.
- Decided: Jul 17, 2024 after 219 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K003122 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190473: ACIST RXi System and Navvus II Catheter, Acist Medical Systems, Inc. (2019) Summary page 5.

## Indications for use
The ACIST RXi System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System.

Source page: https://510kreport.com/device/K233904
Methodology: https://510kreport.com/methodology