# K022187: Pressure Wire Sensor, Models 12003/12303, 12004/12304

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Sep 24, 2002 after 81 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: 1 generation back to K972762 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002962: Pressure Wire Sensor, Model 12003/12303, Radi Medical Systems AB (2000) Summary page 1.
- K972762: Cardiometrics Flowire 300 and XT 300 Doppler Guide Wires, Cardio Metrics, Inc. (1997) Summary page 1.

## Indications for use
The PressureWireTM Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels

Source page: https://510kreport.com/device/K022187
Methodology: https://510kreport.com/methodology