# K161171: PressureWire X Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Inc.
- Decided: Aug 15, 2016 after 111 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: 10 generations back to K003122 (2001). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140466: Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300, St. Jude Medical Systems AB (2014) Summary page 4.

## Most influential descendants
- K180558: PressureWire X (2018), 0 descendants of its own

## Indications for use
The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X Guidewire can also measure blood temperature.

Source page: https://510kreport.com/device/K161171
Methodology: https://510kreport.com/methodology