Vascath Vascular Catheter Placement Kit

FDA-Cleared Indications

• Placement of a vascular catheter through a blood vessel.
• Establishment of vascular access for procedures requiring catheterization of the vascular system.

Clinical Applications

• Obtaining venous or arterial access before catheter-based diagnostic procedures.
• Providing access for interventional radiology and vascular surgery procedures.
• Introducing catheters used for vascular treatment or monitoring.
• Establishing access when a catheter is required for ongoing clinical care.

Reported off-label uses

• Use of vascular access components in procedures outside the kit's specific cleared labeling may occur in clinical practice, but the intended use, component compatibility, and institutional policy should be confirmed before use.

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 kit may include components such as an access needle, guidewire, and dilator; the exact contents and sizes should be verified in the product labeling.
• Clinicians should select the access site, catheter size, and component configuration based on the patient's anatomy and planned procedure.
• All components must be used with sterile technique to reduce bleeding and infection risk.
• Compatibility with the intended catheter and other accessories should be confirmed before insertion.
• MRI safety cannot be determined from the FDA record alone. Review the current manufacturer labeling for the MRI status of each component before an MRI examination.