Corepass Modular Microcatheter Flex Corepass Modular Microcatheter Control

FDA-Cleared Indications

• Percutaneous catheter use within the vascular system.
• Use as an intravascular catheter under fluoroscopic or other appropriate imaging guidance.
• The FDA product-code record does not establish a specific indication for venous stenting, thrombectomy, or treatment of a named disease.

Clinical Applications

• Percutaneous vascular access and navigation during endovascular procedures.
• Delivery or positioning of compatible interventional equipment when permitted by the device labeling and procedural technique.
• Use by trained clinicians in a catheterization or interventional procedure setting.

Reported off-label uses

• Use as an adjunct during venous stent placement for venous obstruction.
• Use as an adjunct during catheter-based treatment of venous thrombosis or post-thrombotic venous disease.

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 available catheter lengths, diameters, working-channel or guidewire compatibility, and modular components in the current manufacturer’s instructions for use.
• Use fluoroscopy or other appropriate imaging guidance and advance the catheter gently to reduce the risk of dissection, perforation, thrombosis, or vessel spasm.
• Compatibility with a specific guidewire, stent delivery system, thrombolysis system, or other device must be verified before use.
• MRI safety and conditional-use requirements are not established in the supplied FDA record; consult the current labeling before MRI.
• Contraindications, warnings, and maximum dwell time should be taken from the current manufacturer’s labeling. This type of catheter is generally intended for procedural use rather than long-term implantation.