Wire Guide Catheter
Lake Region Mfg.
FDA Clearance Information
The wire guide catheter was cleared through the FDA 510(k) pathway on June 26, 1985. It is manufactured by Lake Region Mfg. and classified as a Class 2 device under product code DQY.
What It Is
FDA-Cleared Indications
- Percutaneous catheterization of blood vessels.
- Use as a catheter conduit to support the placement, exchange, or guidance of other vascular instruments.
- Use during vascular procedures requiring controlled catheter positioning under imaging guidance.
Clinical Applications
- Providing support during venous catheter exchanges.
- Facilitating catheter placement for venous stenting procedures.
- Serving as a conduit for guidewires or other compatible instruments during percutaneous vascular procedures.
- Supporting access and instrument positioning in iliac or central venous interventions.
Reported off-label uses
- Use as an access or support catheter during selected embolization procedures when clinically appropriate and compatible with the device specifications.
- Use in complex catheter navigation during neurointerventional procedures, when the device is suitable for the intended anatomy and technique.
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.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The catheter must be selected for the intended vessel, access route, guidewire size, and other device compatibility requirements.
- Available dimensions, lumen configuration, radiopacity, and pressure limits depend on the specific model and its labeling.
- Placement and manipulation should be performed with appropriate imaging guidance by trained clinicians.
- MRI safety is model-specific; the device should not be assumed to be MR Safe or MR Conditional without current manufacturer labeling.
- Potential complications include bleeding, infection, vessel injury, thrombosis, embolization, catheter fracture, and malposition.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for wire guide catheter?
The wire guide catheter is indicated for use in venous-stent procedures, including complex catheter exchanges and embolization of intracranial aneurysms.
What outcomes have been reported in clinical studies?
Studies report successful catheter exchanges and embolization procedures, with techniques enhancing procedural support and reducing complications.
What complications have been reported?
Reported complications include potential air embolism during catheter exchanges, which can be reduced with specific procedural techniques.