Extroducer Infusion Catheter System

FDA-Cleared Indications

• For continuous flushing and infusion during vascular procedures.
• For use by appropriately trained clinicians in hospitals or clinical settings.
• The product code identifies it as a continuous-flush catheter under 21 CFR 870.1210.

Clinical Applications

• Continuous flushing during catheter-based vascular procedures.
• Infusion of fluids or medications through a vascular catheter when specified by the device labeling and procedure protocol.
• Use during image-guided endovascular procedures requiring catheter patency and controlled infusion.

Reported off-label uses

• Use as part of catheter-directed thrombolysis protocols may be considered off-label unless specifically included in the device labeling.
• Use during mechanical thrombectomy procedures may be off-label when the catheter is used for functions beyond its cleared continuous-flush or infusion indication.

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

• Confirm the catheter size, lumen configuration, connector type and compatibility with the guidewire, infusion system and other procedural equipment before use.
• Use only the recommended fluids, medications, pressure limits and infusion rates in the current instructions for use.
• The supplied FDA record does not establish MRI safety; check the current labeling for MR Safe, MR Conditional or MR Unsafe status before MRI.
• Potential contraindications and warnings include infection, vascular injury, bleeding, thrombosis, embolization, air entry and complications related to the infused medication.
• The catheter is intended for trained healthcare professionals and should be inspected for damage, kinking or obstruction before and during use.