đź“‹ FDA Reference

InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

Merit Medical Ireland, Ltd.

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Summary: The InQwire Super Stiff Guide Wire is a sterile, flexible guide wire with extra support for directing compatible catheters and other devices through blood vessels. It is used during endovascular procedures under imaging guidance, including vascular access, diagnostic angiography and device delivery.

FDA Clearance Information

Pathway ? 510(k)
Number ? K251385 ↗
Decision Date ? January 21, 2026
Product Code ? DQX Wire, Guide, Catheter
Device Class ? Class 2
Evidence ? 0 studies

FDA-Cleared Indications

  • For use in the peripheral vasculature to facilitate the placement and exchange of diagnostic and therapeutic devices.
  • Intended for use with appropriately sized intravascular catheters and devices during endovascular procedures.

Clinical Applications

  • Guiding or exchanging catheters during peripheral angiography.
  • Providing support for delivery of compatible balloon catheters and other therapeutic devices in peripheral vessels.
  • Maintaining vascular access while exchanging endovascular devices.
  • Supporting catheter positioning during embolization procedures involving peripheral arteries.

Reported off-label uses

  • Guide-wire support during selected neurointerventional procedures, when the wire's size, stiffness and compatibility are appropriate.
  • Guide-wire support during selected coronary or visceral vascular procedures, when used outside the labeled vascular territory.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

  • Available configurations include 0.035-inch wires in several lengths, including approximately 80, 100, 150, 180 and 260 cm, plus a 0.032-inch, 180-cm configuration; select the length and stiffness for the access route and planned device exchange.
  • The wire must be used with compatible catheters and devices that accept its diameter and tip configuration. Confirm compatibility before insertion.
  • Use fluoroscopic or other appropriate imaging guidance and advance without force. Resistance can indicate vessel spasm, tortuosity, dissection or device incompatibility.
  • Review the current manufacturer instructions for use for contraindications, preparation, torque response, tip handling, storage and single-use requirements.
  • MRI safety depends on the exact model and labeling. Do not assume the wire is MR Safe or MR Conditional; verify the current device-specific MRI information before an MRI examination.

Procedures that use this device

Frequently Asked Questions

What is the InQwire Super Stiff Guide Wire used for?

It provides support for placing, positioning and exchanging compatible catheters and endovascular devices during image-guided vascular procedures, particularly in the peripheral vasculature.

What sizes does the InQwire Super Stiff Guide Wire come in?

The listed configurations include 0.035-inch wires in approximately 80, 100, 150, 180 and 260 cm lengths, as well as a 0.032-inch, 180-cm wire. The available tip and stiffness configuration should be matched to the catheter and procedure.

Is the InQwire Super Stiff Guide Wire MRI safe?

MRI status is model-specific and should be confirmed in the current manufacturer labeling. Do not undergo MRI with the wire in place unless its exact model is identified and the applicable MRI conditions are verified.

How long does an InQwire Super Stiff Guide Wire last?

It is a sterile, single-use device intended for one procedure and should not be resterilized or reused. The treating facility disposes of it after use.

How much does an InQwire Super Stiff Guide Wire cost?

The price is generally not listed publicly and varies by hospital, distributor, contract and insurance arrangements. Patients are usually billed as part of the overall vascular procedure rather than purchasing the guide wire separately.

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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