Silverspeed Hydrophilic Guidewire 0 014 Diameter 145cm Length Support Silverspeed Hydrophilic Guidewire 0 014 D

FDA-Cleared Indications

• Used with compatible intravascular catheters to facilitate navigation through blood vessels during diagnostic or interventional procedures.
• Intended for use in the peripheral vasculature.
• The device is a Class II catheter guidewire cleared through the FDA 510(k) pathway.

Clinical Applications

• Guiding compatible catheters through peripheral arteries during endovascular procedures.
• Supporting catheter navigation through tortuous or narrowed peripheral vascular anatomy.
• Facilitating access during peripheral vascular diagnostic procedures.
• Facilitating access during peripheral endovascular interventions when the guidewire is compatible with the selected catheter.

Reported off-label uses

• Use in selected below-the-knee or other small-vessel interventions may occur in clinical practice, depending on the specific device labeling, anatomy, and operator judgment.
• Some clinicians may use similar 0.014-inch hydrophilic guidewires in other specialized vascular procedures; these applications should not be assumed to be FDA-cleared for this specific device.

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

• The listed device has a 0.014-inch diameter and 145 cm length; the guidewire must be matched to the catheter, access route, target anatomy, and procedure.
• Hydrophilic guidewires should be wetted and handled according to the manufacturer's instructions to maintain coating performance.
• Use fluoroscopic or other appropriate imaging guidance, and avoid advancing against significant resistance because vessel injury, dissection, perforation, or wire damage can occur.
• Confirm MRI labeling before an MRI examination; MRI safety depends on the exact model and labeling, and should not be assumed from the product name alone.
• Potential complications include thrombosis, embolization, vasospasm, vessel injury, infection, and guidewire fracture or entrapment.