Modified Mahurkar Subclavian Femoral Catheters

FDA-Cleared Indications

• Percutaneous catheterization of a central vein to provide temporary vascular access.
• Central venous access for hemodialysis and other extracorporeal blood-treatment procedures.
• Use through the subclavian or femoral venous routes when central venous access is clinically required.

Clinical Applications

• Providing central venous access for hemodialysis.
• Establishing access for extracorporeal blood-treatment procedures.
• Accessing the central circulation through the subclavian vein.
• Accessing the central circulation through the femoral vein.

Reported off-label uses

• Short-term central venous access for administration of medications or fluids in critically ill patients when appropriate for the specific catheter configuration.
• Temporary central venous access for selected intensive-care applications not specifically described in the 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

• Available size and lumen configurations should be selected according to the patient’s anatomy, treatment requirements, and the specific product labeling.
• Placement requires sterile technique, guidewire-based catheterization, and confirmation of appropriate catheter position according to institutional practice.
• The catheter should be connected only to compatible dialysis or infusion equipment and managed using the manufacturer’s instructions.
• MRI safety cannot be determined from the 1986 510(k) record alone; verify the exact catheter model and current labeling before an MRI examination.
• Potential contraindications and complications include infection, bleeding, thrombosis, vessel injury, malposition, and pneumothorax with subclavian access. Use is determined by the treating clinician.