Modification to Supercross Catheter

FDA-Cleared Indications

• Used percutaneously in vascular procedures as a catheter for accessing or treating blood vessels.
• Used with compatible guidewires and other endovascular devices when catheter delivery and positioning are required.

Clinical Applications

• Catheter-based vascular interventions requiring selective vessel access.
• Delivery or positioning of compatible endovascular devices when supported by the product labeling.
• Use in catheterization laboratories and interventional procedure suites under fluoroscopic or other appropriate imaging guidance.

Reported off-label uses

• Use as a support or exchange catheter during complex venous interventions may occur in clinical practice, but the specific indication should be confirmed against the current device labeling.

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 FDA record identifies the device by product code DQY, but does not provide the catheter's full size range, working length, distal configuration, or maximum guidewire compatibility.
• Use only with compatible guidewires, delivery systems, and other devices specified in the current instructions for use.
• Catheter manipulation should be performed under appropriate imaging guidance by clinicians trained in percutaneous vascular procedures.
• MRI safety depends on the exact catheter model and its components; review the current labeling before an MRI examination.
• Contraindications, warnings, storage requirements, and single-use status should be taken from the current manufacturer instructions for use.