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central venous catheter w big-gard
Norton Performance Plastics
Summary: The central venous catheter w big-gard by Norton Performance Plastics is a Class 2 medical device cleared by the FDA for venous access. Key evidence highlights its use in managing venous access complications.
FDA Clearance Information
Pathway
510K
Number
K841828 ↗
Decision Date
July 13, 1984
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The central venous catheter w big-gard was cleared via the FDA 510(k) pathway on July 13, 1984. It is manufactured by Norton Performance Plastics and classified as a Class 2 device.
What It Is
The central venous catheter w big-gard is designed for venous access, allowing for the administration of medications, fluids, and parenteral nutrition. It is intended for use in patients requiring long-term intravenous therapy.
Clinical Applications
Commonly used in intensive care settings, the device facilitates central venous access for patients with difficult peripheral access or requiring long-term intravenous therapy. It is also used in oncology for chemotherapy administration.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and systematic reviews, published between 2024 and 2025. These studies explore the device's safety and efficacy in clinical practice.
Reported Outcomes
Published studies report that the central venous catheter w big-gard is effective in providing reliable venous access for long-term therapy. It is associated with reduced incidence of peripheral venous stenosis compared to other access methods.
Safety Profile
Reported complications include catheter-related thrombosis and infection, which are common risks associated with central venous catheters. The incidence of these complications varies based on patient characteristics and catheter type.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations. Further research is needed to optimize anticoagulation strategies and reduce complication rates in specific patient groups.
Frequently Asked Questions
What are the clinical indications for central venous catheter w big-gard?
The device is indicated for patients requiring long-term intravenous therapy, such as chemotherapy, parenteral nutrition, or difficult peripheral access.
What outcomes have been reported in clinical studies?
Studies have reported effective venous access with reduced peripheral stenosis compared to other methods.
What complications have been reported?
Safety data indicate risks of catheter-related thrombosis and infection, common to central venous catheters.
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.