Catheter Introducer Kit

FDA-Cleared Indications

• Facilitate the percutaneous introduction of catheters into the vascular system.
• Provide vascular access for placement of diagnostic or therapeutic catheters, including pulmonary artery catheters.
• Use in procedures requiring catheter access to the central or peripheral vascular system.

Clinical Applications

• Introduction of pulmonary artery catheters.
• Establishing vascular access for diagnostic catheterization.
• Establishing vascular access for therapeutic endovascular catheter procedures.
• Catheter insertion in critical care, cardiology and other settings requiring vascular access.

Reported off-label uses

• Access for interventional radiology procedures such as arterial embolization, when the specific kit and components are suitable for the procedure.
• Access for neurointerventional procedures, when the device is compatible with the required catheter system and vessel size.

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

• Select the introducer sheath diameter and length to match the catheter, guidewire and target vessel; available sizes vary by product configuration.
• Confirm compatibility among the sheath, dilator, guidewire and catheter before use.
• Use sterile technique and flush components as directed to reduce thrombus formation and air entry.
• Potential complications include bleeding, hematoma, vessel injury, thrombosis, infection and air embolism.
• MRI safety depends on the specific components and materials. Review the current product labeling; do not assume MRI compatibility based only on the device category.