📋 FDA Reference

EmeryGlide™ (EG18008901)

Nano4Imaging GmbH

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Summary: EmeryGlide (EG18008901) is a guidewire used to help guide and position catheters and other compatible devices during minimally invasive vascular procedures. It is cleared as a Class II medical device under the FDA guidewire product category.

FDA Clearance Information

Pathway ? 510(k)
Number ? K253262 ↗
Decision Date ? March 6, 2026
Product Code ? DQX Wire, Guide, Catheter
Device Class ? Class 2
Evidence ? 0 studies

FDA-Cleared Indications

  • For use in the vascular system to facilitate the placement and positioning of compatible catheters and other interventional devices.
  • Intended for use by trained healthcare professionals during diagnostic or interventional procedures requiring guidewire access.

Clinical Applications

  • Establishing and maintaining vascular access during catheter-based procedures.
  • Guiding compatible catheters through peripheral blood vessels.
  • Supporting catheter positioning during angiography and endovascular interventions.
  • Providing wire guidance during procedures involving selected arterial or venous anatomy, according to the device labeling and compatibility requirements.

Practical Considerations

  • Use only with compatible catheters, introducer sheaths and other devices, following the manufacturer’s instructions for use.
  • The available wire diameter, length, tip design and coating should match the access site, target vessel and catheter system.
  • Use fluoroscopic or other appropriate imaging guidance and avoid excessive force, which can cause vessel injury, wire damage or entanglement.
  • MRI safety and conditions should be confirmed in the current manufacturer’s labeling before scanning; this record does not establish that the device is MR Safe or MR Conditional.
  • Contraindications, warnings and handling requirements should be checked in the current FDA-cleared labeling and instructions for use.

Procedures that use this device

Frequently Asked Questions

What is the EmeryGlide guidewire used for?

EmeryGlide is used to guide and position compatible catheters and other devices within the vascular system during minimally invasive procedures. Its specific use depends on the catheter system, vessel anatomy and FDA-cleared labeling.

Is EmeryGlide MRI safe?

MRI safety cannot be determined from the FDA product category alone. Check the current Nano4imaging instructions for use for the device’s MR Safe, MR Conditional or MR Unsafe status and any scanning conditions.

What sizes does EmeryGlide come in?

Available diameters, lengths, tip configurations and coating specifications should be confirmed in the current manufacturer product documentation. Select the size that is compatible with the intended catheter and access system.

How long does the EmeryGlide guidewire last?

EmeryGlide is generally a single-use device and is not intended for reuse or resterilization. It is used for one procedure and then discarded according to facility policy.

How much does EmeryGlide cost?

The price is not fixed and may vary by supplier, configuration, contract and healthcare facility. Patients should ask the hospital or procedure center about device-related charges and insurance coverage.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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