# K190473: ACIST RXi System and Navvus II Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems, Inc.
- Decided: Sep 13, 2019 after 198 days
- Product code: OBI (Catheter, Pressure Monitoring, Cardiac)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003122 (2001). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132474: Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter, Acist Medical Systems (2014) Summary page 6.

## Most influential descendants
- K233904: ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (2024), 0 descendants of its own

## 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/K190473
Methodology: https://510kreport.com/methodology