# K180558: PressureWire X

- Pathway: 510(k) (Special)
- Applicant: St. Jude Medical (Now Part of Abbott Medical)
- Decided: Mar 28, 2018 after 27 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: 11 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)
- K161171: PressureWire X Guidewire, St. Jude Medical, Inc. (2016) Summary page 4.

## 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/K180558
Methodology: https://510kreport.com/methodology