# K190852: Zurich Pressure Guidewire System Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Zurich Medical, Inc.
- Decided: Aug 14, 2019 after 134 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: 9 generations back to K003122 (2001). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131452: Pressurewire; Certus, Certus 300, Aeris, Aeris 300, St. Jude Medical Systems AB (2013) Summary page 5.
- K092105: Radianalyzer Xpress, Radi Medical Systems AB (2009) Summary page 5.

## Indications for use
Zurich Pressure Guidewire System is indicated to measure physiological parameters in the coronary and peripheral blood vessels and in the heart. Zurich Pressure Guidewire System is also indicated to direct a catheter through a blood vessel.

Source page: https://510kreport.com/device/K190852
Methodology: https://510kreport.com/methodology