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multi-lumen central venous catheter set
Arrow Intl.
Summary: The multi-lumen central venous catheter set by Arrow Intl. is used for venous access in various clinical settings. Key evidence highlights its role in managing central line-associated bloodstream infections (CLABSI).
FDA Clearance Information
Pathway
510K
Number
K904404 ↗
Decision Date
February 15, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The multi-lumen central venous catheter set was cleared by the FDA via the 510k pathway on February 15, 1991. It is manufactured by Arrow Intl. and classified as a Class 2 device.
What It Is
The multi-lumen central venous catheter set is designed to provide venous access for administering medications, fluids, and for monitoring central venous pressure. It is intended for use in critical care and surgical settings.
Clinical Applications
Commonly used in intensive care units and operating rooms, this device facilitates the administration of medications, fluid resuscitation, and hemodynamic monitoring in patients requiring central venous access.
Evidence Summary
The literature includes a mix of retrospective and prospective studies, with a focus on infection risks and prevention strategies. The studies span from 2004 to 2025, highlighting ongoing research in this area.
Reported Outcomes
Published studies report that routine changing of intravenous administration sets does not significantly reduce colonization or infection rates in central venous catheters. Additionally, machine learning models have been developed to predict CLABSI risk in ICU patients.
Safety Profile
Reported complications include potential infectious risks associated with indwelling central venous catheters, as highlighted in microbiological evaluations of pediatric patients.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and optimal infection prevention strategies.
Frequently Asked Questions
What are the clinical indications for multi-lumen central venous catheter set?
The device is indicated for venous access in critical care and surgical settings, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported on infection risks and the effectiveness of infection prevention strategies, including the use of machine learning for CLABSI risk prediction.
What complications have been reported?
Safety data indicate infectious complications as a primary concern, with microbiological evaluations highlighting risks in pediatric patients.
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.