📋 FDA Reference

Quinton Mahurkar Catheters W Vitacuff

Quinton

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Summary: The Quinton Mahurkar Catheters with Vitacuff are used for venous access, primarily in dialysis patients. They are typically used by nephrologists and interventional radiologists.

FDA Clearance Information

Pathway ? 510(k)
Number ? K895440 ↗
Decision Date ? November 29, 1989
Product Code ? DQY Catheter, Percutaneous
Device Class ? Class 2
Evidence ? 0 studies

The Quinton Mahurkar Catheters with Vitacuff were cleared through the FDA 510(k) pathway on November 29, 1989. Manufactured by Quinton, this device is classified as Class 2 under product code DQY.

What It Is

The Quinton Mahurkar Catheters with Vitacuff are specialized catheters designed for venous access, often used in patients requiring dialysis. The Vitacuff feature helps reduce infection risk by providing a barrier at the catheter exit site. These catheters are inserted into large veins, typically in the neck or groin, to facilitate efficient blood flow during dialysis sessions.

FDA-Cleared Indications

  • Venous access for hemodialysis.
  • Use in patients who require temporary or longer-term central venous access for dialysis, according to the applicable device labeling.

Clinical Applications

  • Providing vascular access for hemodialysis in patients with kidney failure.
  • Providing dialysis access when an arteriovenous fistula or graft is not available, mature, or usable.
  • Providing access for patients with acute kidney injury who require dialysis.
  • Use as a tunneled central venous dialysis catheter placed through a large vein.

Reported off-label uses

  • Use as central venous access for selected non-dialysis infusions or blood sampling has been reported for tunneled catheter types, but this is not the primary labeled use and should follow institutional policy.
  • Use for selected extracorporeal blood-treatment procedures other than hemodialysis may occur in practice, depending on catheter specifications 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

  • Common access routes include the internal jugular vein, usually in the neck, and less commonly the femoral vein or other central venous routes. Placement is generally performed with ultrasound and fluoroscopic or other imaging guidance.
  • The catheter must be selected with the appropriate lumen configuration, length, and diameter for the patient's anatomy and the dialysis system. It must be compatible with standard dialysis connectors and equipment.
  • Strict sterile technique, appropriate tunneling, securement, and catheter-site care are important because central venous dialysis catheters can cause bloodstream infection, thrombosis, bleeding, and malfunction.
  • MRI safety is configuration-specific. The exact catheter labeling and facility MRI policy should be checked before scanning; do not assume that every Quinton Mahurkar catheter with Vitacuff is MR safe or MR conditional.
  • Contraindications and precautions may include infection at the intended insertion site, uncorrected severe bleeding risk, thrombosis or occlusion of the target vein, and inability to safely access or traverse the central venous system.

Frequently Asked Questions

What is the Quinton Mahurkar Catheter with Vitacuff used for?

It is used for providing venous access in patients requiring dialysis, particularly in those with chronic kidney disease.

What specialties typically use this device?

Nephrologists and interventional radiologists commonly use this device for dialysis access.

What are the FDA-cleared indications?

The device is indicated for venous access in patients needing dialysis, such as those with end-stage renal disease.

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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