📋 FDA Reference

Triple Lumen Infusion Catheterization Set or Kit

Medical Surgical Concepts

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Summary: The triple lumen infusion catheterization set is a medical device used for administering medications and fluids intravenously. It is commonly used by healthcare professionals in hospital settings, particularly in critical care and surgery.

FDA Clearance Information

Pathway ? 510(k)
Number ? K870412 ↗
Decision Date ? May 27, 1987
Product Code ? DQY Catheter, Percutaneous
Device Class ? Class 2
Evidence ? 0 studies

This device was cleared through the FDA 510(k) pathway on May 27, 1987. It is manufactured by Medical Surgical Concepts and classified as a Class 2 medical device.

What It Is

The triple lumen infusion catheterization set is a central venous catheter with three separate lumens, allowing for the simultaneous administration of multiple medications or fluids. It is inserted into a large vein, typically in the neck, chest, or groin, and is used for patients requiring long-term intravenous therapy. The device facilitates efficient management of complex medication regimens and fluid administration.

FDA-Cleared Indications

  • Intravenous administration of medications
  • Intravenous administration of fluids
  • Establishment of central venous access when multiple intravenous infusions are required

Clinical Applications

  • Administering multiple intravenous medications or fluids through separate lumens
  • Providing central venous access during critical care
  • Providing central venous access during major surgery
  • Separating infusions that are not compatible when used according to labeling and institutional protocols

Reported off-label uses

  • Administration of parenteral nutrition through a designated lumen when the catheter and formulation are compatible
  • Central venous pressure monitoring when the catheter configuration and monitoring equipment support it

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 catheter sizes and lengths should be selected according to the patient's anatomy, the access vein, and the intended therapy.
  • Placement is commonly performed using sterile technique and imaging guidance, such as ultrasound, with the catheter tip position confirmed according to institutional practice.
  • Medication and fluid compatibility should be checked before using separate lumens; each lumen requires appropriate flushing and securement.
  • Risks include bleeding, arterial puncture, infection, thrombosis, air embolism, catheter malposition, and vessel or lung injury depending on the access site.
  • MRI safety is not determined by the product name alone. Confirm the exact catheter materials and labeling before an MRI examination, and follow the facility's MRI safety protocol.

Related Literature

The linked study investigated the feasibility of using a standard central venous catheter for slow continuous ultrafiltration (SCUF) in patients with heart failure. The study demonstrated that SCUF could be performed using a standard catheter, potentially reducing fluid overload in patients unresponsive to medical therapy. However, the study was conducted in vitro, and further clinical research is needed to confirm these findings in real-world settings.

Procedures that use this device

Frequently Asked Questions

What is the triple lumen infusion catheterization set used for?

It is used for the intravenous administration of medications and fluids, particularly in patients requiring long-term or complex infusion therapy.

What specialties typically use this device?

This device is commonly used in critical care, surgery, and oncology by healthcare professionals managing patients with complex medical needs.

What are the FDA-cleared indications?

The device is indicated for the intravenous administration of medications and fluids, suitable for patients needing long-term venous access.

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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