Safe-Cross Deflecting Catheter Model C118ND1

FDA-Cleared Indications

• Use as a percutaneous catheter for intravascular procedures, consistent with FDA product code DQY.
• Use by trained clinicians to access and navigate blood vessels during an indicated endovascular procedure.

Clinical Applications

• Catheter navigation within the venous system when directional control is needed.
• Access and positioning during endovascular treatment of venous disease, when consistent with the specific procedure and labeling.
• Use as an accessory catheter during venous interventions performed by interventional radiology or vascular surgery teams.

Reported off-label uses

• Use to assist with complex venous stent delivery or positioning beyond the specific cleared labeling may be considered off-label and should be based on clinician judgment, institutional policy, and available evidence.

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 supplied FDA record does not list the catheter's available sizes, working length, tip dimensions, guidewire compatibility, or maximum pressure; clinicians should verify these details in the current manufacturer instructions for use.
• A deflectable tip requires controlled manipulation under appropriate fluoroscopic or other compatible imaging guidance by clinicians trained in catheter and guidewire techniques.
• MRI safety and conditional-use requirements are not established by the information provided; verify the current labeling before MRI exposure.
• Potential contraindications, warnings, and complications should be reviewed in the current instructions for use and may include vascular injury, bleeding, thrombosis, embolization, infection, and catheter damage.
• The catheter is a procedural device and is not intended to remain implanted after the intervention unless the product labeling specifically states otherwise.