📋 FDA Reference

Mahurkar Dual Limen Femoral Catheter

Quinton

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Summary: The Mahurkar Dual Lumen Femoral Catheter is a medical device used for venous access, primarily in dialysis patients. It is typically used by nephrologists and interventional radiologists.

FDA Clearance Information

Pathway ? 510(k)
Number ? K834109 ↗
Decision Date ? February 4, 1984
Product Code ? DQY Catheter, Percutaneous
Device Class ? Class 2
Evidence ? 0 studies

The Mahurkar Dual Lumen Femoral Catheter was cleared through the FDA 510(k) pathway on February 4, 1984. Manufactured by Quinton, it is classified as a Class 2 device under product code DQY.

What It Is

The Mahurkar Dual Lumen Femoral Catheter is a specialized catheter designed for temporary venous access. It features two lumens, allowing for simultaneous infusion and withdrawal of fluids, which is particularly useful in hemodialysis. The catheter is inserted into the femoral vein, providing a reliable and efficient route for blood flow during treatment.

FDA-Cleared Indications

  • Temporary percutaneous venous access for hemodialysis.
  • Hemodialysis access when a temporary central venous catheter is clinically required.

Clinical Applications

  • Temporary hemodialysis access in patients with acute kidney injury.
  • Hemodialysis while a permanent vascular access, such as an arteriovenous fistula or graft, is being created or matures.
  • Hemodialysis when other suitable venous access sites are unavailable or cannot be used.

Reported off-label uses

  • Temporary large-bore venous access for selected extracorporeal blood therapies other than routine hemodialysis, when permitted by institutional policy and clinical judgment.

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 catheter is inserted into the femoral vein using sterile technique and, when available, ultrasound and fluoroscopic guidance.
  • It is intended for temporary use rather than long-term dialysis access; femoral placement generally has greater infection and thrombosis concerns than some alternative access sites.
  • The catheter size and length must match the patient's anatomy, dialysis requirements, and insertion site.
  • It must connect to compatible dialysis tubing and equipment, with careful flushing, clamping, and dressing care to reduce air entry, clotting, and infection.
  • MRI safety depends on the exact catheter materials and labeling. Confirm the device-specific MRI conditions before scanning; do not assume that an older catheter is MRI safe.

Procedures that use this device

Frequently Asked Questions

What is the Mahurkar Dual Lumen Femoral Catheter used for?

It is used for temporary venous access in patients requiring hemodialysis, particularly in acute settings.

What specialties typically use this device?

Nephrologists and interventional radiologists commonly use this device in hospital settings.

What are the FDA-cleared indications?

The catheter is indicated for temporary venous access in patients needing hemodialysis, especially when other access sites are not viable.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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