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PressureWire X Guidewire

by St. Jude Medical, Inc.

510(k) K161171

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161171 Date15 Aug 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DXO
Device class
Class II
Regulation
21 CFR Part 870.2870
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PressureWire X Guidewire is a Transducer, Pressure, Catheter Tip, designed for coronary physiology assessment. It measures intracoronary pressure and temperature wirelessly, enabling precise evaluation of coronary artery function, including fractional flow reserve (FFR).

This device is supplied as a single-use guidewire and is intended for use in cardiac catheterization laboratories. It requires careful handling to maintain sensor integrity and accuracy, with the transmitter kept dry during operation. Authorized under FDA 510(k) clearance (K161171), it adheres to Class II regulatory standards for pressure measurement devices.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical applications is the PressureWire X Guidewire primarily used for in cardiac catheterization labs?

    The PressureWire X Guidewire is designed specifically for coronary physiology assessment, allowing precise measurement of intracoronary pressure and temperature. This enables clinicians to evaluate coronary artery function, particularly for calculating fractional flow reserve (FFR), which helps determine the physiological significance of coronary stenosis and guides revascularization decisions.

  • Is the PressureWire X Guidewire reusable, or is it intended for single-use only?

    The PressureWire X Guidewire is intended for single-use only. Since it is a catheter-tip pressure transducer, its sensor integrity and accuracy depend on careful handling, and reuse could compromise performance or introduce contamination risks. Always follow manufacturer guidelines to avoid compromising measurements.

  • What special handling precautions should be taken when using the PressureWire X Guidewire?

    The device requires strict handling to maintain sensor accuracy, particularly keeping the transmitter dry during operation. Moisture exposure can interfere with wireless signal transmission and compromise measurement reliability. Additionally, since it’s single-use, ensure proper disposal after use to prevent cross-contamination.

  • How is the PressureWire X Guidewire regulated, and what does that mean for clinicians?

    The PressureWire X Guidewire is authorized under FDA 510(k) clearance (K161171) and classified as a Class II medical device for pressure measurement. This means it has undergone premarket review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and performance standards for coronary physiology assessments in clinical settings.