6f Proxis System

FDA-Cleared Indications

• For use as a percutaneous catheter device in vascular procedures, consistent with FDA product code DQY.
• The available FDA summary does not provide a more specific indication statement for the 6F Proxis System.

Clinical Applications

• Percutaneous catheter-based vascular procedures within the device's labeled indications.
• Use by trained clinicians when vascular access and catheter manipulation are required.

Reported off-label uses

• Use as a delivery or access system for venous stenting may occur in clinical practice, but this use should not be assumed to be FDA-labeled without reviewing the manufacturer's complete instructions for use.
• Use during catheter-based treatment of venous obstruction may be considered by clinicians only when clinically appropriate and consistent with institutional policy.

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 device is identified as a 6F system; clinicians should confirm the required sheath, guidewire, catheter, and stent compatibility in the current instructions for use.
• Confirm the intended anatomy, access route, working length, and device dimensions before the procedure.
• The available record does not establish MRI safety. Review the current labeling for MR Safe, MR Conditional, or MR Unsafe status before MRI.
• Use requires percutaneous vascular access, imaging guidance, and clinicians trained in catheter-based vascular procedures.
• Contraindications, warnings, and handling requirements should be taken from the current manufacturer labeling; they cannot be determined from the FDA product code alone.