# K983506: Pressurewire Sensor, Model #12001

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Feb 3, 1999 after 119 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K972793 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972793: Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor Cable, Radi Medical Systems AB (1998) Summary page 1.

## Indications for use
The PressureWire Sensor is intended for use in coronary and peripheral blood vessels to measure blood pressure during percutaneous procedures and to facilitate the placement of interventional devices.

Source page: https://510kreport.com/device/K983506
Methodology: https://510kreport.com/methodology