Cordis Cath Sheath Introduc Mid-Length Sheath Syst

FDA-Cleared Indications

• Facilitates percutaneous introduction of catheters and other intravascular devices into the vascular system.
• Provides vascular access during diagnostic and interventional catheter-based procedures.
• Supports the passage and exchange of compatible catheters or devices while maintaining access to the vessel.

Clinical Applications

• Vascular access for angiography and other diagnostic imaging procedures.
• Access for catheter-based vascular interventions, including angioplasty and stent procedures.
• Access for embolization procedures when compatible catheters or embolic delivery systems are used.
• Temporary access for introducing and exchanging compatible intravascular devices.

Reported off-label uses

• Use as an access sheath for specialized neurointerventional procedures when the sheath specifications are appropriate.
• Use for selected venous interventions or other catheter-based procedures outside the original labeled application, based on clinician judgment and device compatibility.

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 sheath and dilator must be selected to match the target vessel, access site, catheter diameter and procedural requirements.
• The system is intended for temporary procedural use; it is not an implant designed to remain in the vessel after the procedure.
• Use sterile technique and appropriate imaging guidance, such as ultrasound and fluoroscopy, to reduce the risk of bleeding, vessel injury, infection and malposition.
• Confirm compatibility with the guidewire, catheter and other devices before use; excessive force can damage the vessel or device.
• MRI safety depends on the exact model and materials. Because this record does not provide model-specific MRI labeling, consult the current Cordis instructions for use and MRI conditions before scanning.