Pvs 1400 Guide Wite with Hydrophilic Coating

FDA-Cleared Indications

• For use as a guide wire to facilitate the placement and positioning of catheters and other vascular devices.
• For use in vascular procedures involving liquid embolization agents, when used with compatible catheters and embolization systems.

Clinical Applications

• Guiding compatible catheters through blood vessels during vascular interventions.
• Facilitating delivery of liquid embolization agents during indicated embolization procedures.
• Helping obtain access through tortuous or difficult vascular anatomy when the device is used according to its labeling.

Reported off-label uses

• Guide-wire support during angioplasty or stent-placement procedures may be reported for guide wires of this general type, but use is off-label unless specifically included in the device's labeling.
• Navigation during selected diagnostic angiographic procedures may be reported for this device category, but the specific use should be confirmed against the current instructions for use.

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 record indicates that the device is available in different lengths and diameters; the appropriate size depends on the access route, target vessel, catheter compatibility and procedure.
• Use only with compatible catheters and other devices specified by the manufacturer.
• The hydrophilic coating should be kept wet and handled according to the instructions for use to reduce coating damage and friction.
• The FDA record provided does not establish MRI safety. MRI compatibility or conditional use should be confirmed in the current labeling before an MRI examination.
• Contraindications, warnings and maximum guide-wire advancement limits should be checked in the current instructions for use; excessive force can cause vessel injury or device damage.