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ac 3 lumen central venous access kit with arrowg ard antimicrobial surface
Arrow Intl.
Summary: The AC 3 Lumen Central Venous Access Kit with Arrowgard Antimicrobial Surface is a device used for central venous access, primarily to reduce infection risk. Key evidence highlights its role in minimizing central line-associated bloodstream infections (CLABSI).
FDA Clearance Information
Pathway
510K
Number
K032962 ↗
Decision Date
October 29, 2003
Product Code
FOZ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on October 29, 2003, by Arrow Intl. It is classified as a Class 2 medical device under product code FOZ.
What It Is
The AC 3 Lumen Central Venous Access Kit is designed for central venous access with an antimicrobial surface to reduce infection risk. It is used in clinical settings for patients requiring long-term intravenous therapy.
Clinical Applications
Commonly used in scenarios requiring central venous access, such as chemotherapy, parenteral nutrition, and hemodynamic monitoring. It provides a reliable means of vascular access while aiming to reduce infection rates.
Evidence Summary
The literature includes 9 studies, primarily retrospective and prospective in nature, spanning from 2023 to 2025. These studies focus on infection rates and device efficacy.
Reported Outcomes
Published studies report a reduction in central line-associated bloodstream infections (CLABSI) when using the AC 3 Lumen Central Venous Access Kit. The device's antimicrobial surface is highlighted as a key factor in reducing infection rates.
Safety Profile
Reported complications include central line-associated bloodstream infections (CLABSI), inadvertent dislocation, exit-site hemorrhage, and local infection. These are common risks associated with central venous access devices.
Evidence Limitations
The evidence is limited by the retrospective nature of some studies and a focus on infection outcomes. Further research is needed to explore long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for AC 3 Lumen Central Venous Access Kit?
The device is indicated for central venous access in patients requiring long-term intravenous therapy, such as chemotherapy or parenteral nutrition.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in central line-associated bloodstream infections (CLABSI) with the use of this device.
What complications have been reported?
Reported complications include CLABSI, inadvertent dislocation, exit-site hemorrhage, and local infection.
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.