📊 Evidence-Based Reference
Double Lumen Infusion Catheters
Summary: Double lumen infusion catheters are used for simultaneous infusion and withdrawal of fluids. Primarily used in venous access for various clinical settings. Key evidence highlights their efficacy in maintaining venous access and reducing occlusion rates.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K840175 ↗
Decision Date ?
February 10, 1984
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The double lumen infusion catheters by Medical Components were cleared via the FDA 510(k) pathway on February 10, 1984. They are classified as Class 2 devices under product code DQY.
What It Is
Double lumen infusion catheters are medical devices designed for the simultaneous infusion and withdrawal of fluids. They are primarily used in clinical settings requiring reliable venous access, such as in central venous catheterization.
FDA-Cleared Indications
- Percutaneous catheterization of a vessel for infusion and withdrawal of fluids.
- Simultaneous or sequential administration and removal of fluids through separate catheter lumens.
- Use when vascular access is needed for clinical fluid-management procedures.
Clinical Applications
- Central venous access for infusion of intravenous fluids and medications.
- Withdrawal of blood or other fluids while maintaining a separate infusion channel.
- Vascular access during procedures requiring simultaneous infusion and fluid removal.
- Venous access in selected hospital and procedural settings when a double-lumen catheter is appropriate.
Reported off-label uses
- Temporary access for extracorporeal therapies, including selected dialysis or extracorporeal support applications, when the specific catheter labeling does not include that use.
- Administration of parenteral nutrition through a dedicated lumen when permitted by the treating institution and catheter-specific instructions.
- Infusion of medications that require separate lumens in critical-care settings.
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.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials and other study types, conducted between 2021 and 2025. These studies evaluate the efficacy and safety of double lumen catheters in various clinical settings.
Reported Outcomes
Published studies report that double lumen infusion catheters are effective in maintaining venous access and reducing the incidence of catheter occlusion. They are also noted for their role in enhancing patient mobilization and rehabilitation during ECMO.
Safety Profile
Reported complications include potential catheter occlusion and phlebitis due to turbulence from pulsatile flushing techniques. However, continuous low-speed infusion techniques have been shown to mitigate these risks.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations. Further research is needed to explore long-term outcomes and optimize catheter design for specific clinical applications.
Practical Considerations
- Available catheter lengths, French sizes, lumen diameters, tip configurations, and flow rates vary by model; selection depends on the vessel, treatment, and required flow.
- Use only compatible fluids, medications, guidewires, connectors, and infusion equipment according to the catheter instructions for use.
- Placement is typically performed using sterile technique and imaging guidance, with the access vessel and tip position confirmed before use.
- MRI safety depends on the exact catheter model and any included components; check the current manufacturer labeling before an MRI examination.
- Potential complications include infection, bleeding, thrombosis, vessel injury, air embolism, malposition, leakage, and catheter occlusion.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for double lumen infusion catheters?
Double lumen infusion catheters are indicated for use in patients requiring reliable venous access for long-term intravenous therapy, such as those undergoing digestive surgery or ECMO.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective maintenance of venous access and reduced catheter occlusion rates with the use of double lumen infusion catheters.
What complications have been reported?
Safety data from evidence indicate complications such as catheter occlusion and phlebitis, though continuous low-speed infusion techniques can reduce these risks.
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.