PressureWire Sensor, Model #12001
by Radi Medical Systems AB 510(k)
Active
510(k) K983506
Overview
The PressureWire Sensor, Model #12001, is a steerable guidewire (0.014" diameter, 175 cm length) with an integrated pressure sensor positioned proximal to a 3 cm shapeable radiopaque tip. It is classified as a coronary and peripheral intravascular pressure measurement device, designed for use during percutaneous interventional procedures to assess haemodynamic parameters in the vasculature.
This device is supplied as a single-use, non-sterile product and requires connection to a PressureWire Interface via a detachable cable. It is intended for use in MRI-unsafe environments due to its metallic components. The device holds an FDA 510(k) clearance under the product code DQX and is regulated under the Traditional 510(k) pathway. Storage and handling instructions are specified in the manufacturer’s documentation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983506 | Date3 Feb 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Radi Medical Systems AB
Questions
What types of medical procedures is the PressureWire Sensor, Model #12001, designed to assist with, and where is it used in the body?
The PressureWire Sensor, Model #12001, is specifically designed for use during percutaneous interventional procedures to measure haemodynamic parameters in the coronary and peripheral vasculature. It is inserted via a catheter into blood vessels to assess pressure gradients, helping clinicians evaluate blood flow and guide treatments like angioplasty or stent placement.
Is the PressureWire Sensor, Model #12001, intended for reuse, or is it meant to be used only once?
The PressureWire Sensor, Model #12001, is explicitly labeled as a single-use device. It is not designed for reuse, and each unit should be discarded after a single procedure to ensure patient safety and measurement accuracy.
How is the PressureWire Sensor, Model #12001, supplied, and what additional equipment is required for use?
The PressureWire Sensor, Model #12001, is supplied as a non-sterile product and must be connected to a PressureWire Interface via a detachable cable before use. Sterilization is not required prior to use, but the device must be handled according to the manufacturer’s instructions to ensure proper functionality.
Can the PressureWire Sensor, Model #12001, be used in an MRI environment, and why?
No, the PressureWire Sensor, Model #12001, is not intended for MRI environments due to its metallic components, which could pose safety risks in magnetic resonance settings. It is explicitly designed for use in MRI-unsafe clinical areas only.
What regulatory pathway was followed for the FDA clearance of the PressureWire Sensor, Model #12001, and what does this mean for its use?
The PressureWire Sensor, Model #12001, received FDA 510(k) clearance under the Traditional 510(k) pathway, classified under product code DQX and reviewed by the Cardiovascular (CV) Advisory Committee. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for coronary and peripheral intravascular pressure measurement.