Fluoro-Tip R Hemostasis Valve Introducer Set

FDA-Cleared Indications

• Facilitates the insertion of catheters and other devices into the vascular system.
• Facilitates catheter exchange during vascular procedures.
• Provides vascular access for procedures involving embolization devices, including embolization coils.

Clinical Applications

• Vascular access for diagnostic angiography.
• Catheter insertion and exchange during endovascular procedures.
• Access for embolization procedures using coils or other embolic devices.
• Vascular access for interventional radiology and cardiology procedures requiring repeated device exchanges.

Reported off-label uses

• Use as an access sheath for selected peripheral vascular interventions when the device size and configuration are appropriate.
• Use during selected neurointerventional procedures as an access component when compatible with the planned catheter system.

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

• Choose the introducer size and valve configuration to match the catheter or device being used; available sizes and configurations depend on the specific product packaging.
• Use fluoroscopic or other appropriate imaging guidance and standard sterile vascular-access technique.
• The hemostasis valve helps reduce blood leakage and air entry but does not eliminate the risks of bleeding, vessel injury, thrombosis, infection, or air embolism.
• The device should be inspected before use and handled according to the current manufacturer instructions for use.
• MRI safety is not established by the FDA record provided. Confirm the exact product labeling and MRI conditions before an MRI examination; do not assume it is safe simply because it is used during fluoroscopy.