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double lumen infusion catheters
Medical Components
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
510K
Number
K840175 ↗
Decision Date
February 10, 1984
Product Code
DQY
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.
Clinical Applications
These catheters are commonly used in scenarios requiring long-term intravenous therapy, such as in patients undergoing digestive surgery or those needing extracorporeal membrane oxygenation (ECMO). They facilitate efficient fluid management and medication delivery.
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.
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.