# K132474: Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems
- Decided: Jan 30, 2014 after 176 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: 6 generations back to K003122 (2001). 13 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062769: Pressurewire Certus, Models 12006 and 12306, Radi Medical Systems AB (2006) Summary page 5.

## Most influential descendants
- K141275: Endophys Pressure Sensing Sheath Kit (2015), 4 descendants of its own
- K160272: Endophys Pressure Sensing Sheath Kit (2016), 3 descendants of its own
- K141615: Endophys Blood Pressure Monitor (2015), 2 descendants of its own
- K190473: ACIST RXi System and Navvus II Catheter (2019), 1 descendant of its own
- K173399: Endophys Pressure Sensing Sheath Kit- 8F (2017), 1 descendant of its own

## Indications for use
The ACIST Rapid Exchange (RXI) System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The Navvus Catheter is intended for use with the ACIST RXi System.

Source page: https://510kreport.com/device/K132474
Methodology: https://510kreport.com/methodology