# K972793: Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor Cable

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Apr 24, 1998 after 270 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
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACS Guidewires: named in the summary without a submission number
- (no number) Millar Pressure Measurement System: named in the summary without a submission number

## Most influential descendants
- K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver (2008), 13 descendants of its own
- K113584: Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver (2012), 8 descendants of its own
- K131452: Pressurewire; Certus, Certus 300, Aeris, Aeris 300 (2013), 7 descendants of its own
- K140466: Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300 (2014), 2 descendants of its own
- K111201: C7 XR Imaging System (2011), 2 descendants of its own

## Indications for use
The PressureWire™ System is indicated for the measurement of blood pressure in the coronary vasculature and to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA).

Source page: https://510kreport.com/device/K972793
Methodology: https://510kreport.com/methodology