Burron Percutaneous Inducer Set

FDA-Cleared Indications

• Percutaneous catheterization of blood vessels to provide access for compatible diagnostic or therapeutic devices.
• Introduction of catheters or other interventional devices into the vascular system through a percutaneous access site.

Clinical Applications

• Establishing percutaneous venous access for catheter-based vascular procedures.
• Providing access for placement of venous stents when the selected stent and delivery system are compatible with the introducer set.
• Maintaining a working access tract during catheter-based evaluation or treatment of venous obstruction.
• Use in interventional radiology or vascular surgery procedures requiring sheath-and-dilator venous access.

Reported off-label uses

• Use as an access conduit for selected venous thrombectomy or thrombolysis devices when compatible with the device instructions for use.
• Use for other catheter-based venous interventions not specifically described in the original labeling, based on operator judgment and institutional practice.

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 available sizes, working length, sheath diameter, and dilator dimensions should be confirmed in the current product labeling before use.
• The introducer must be compatible with the planned catheter, guidewire, stent delivery system, and vascular access site.
• It is inserted percutaneously, commonly through a femoral or other suitable venous access site, using imaging guidance and sterile technique.
• Potential complications include bleeding, hematoma, infection, venous injury, thrombosis, air embolism, and difficulty removing or advancing devices.
• MRI safety cannot be determined from the FDA classification or 510(k) record alone. Check the current manufacturer labeling for MR Safe, MR Conditional, or MR Unsafe status before an MRI examination.