đź“Š Evidence-Based Reference
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 ?
510(k)
Number ?
K841828 ↗
Decision Date ?
July 13, 1984
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheterization of a central vein for venous access.
- Administration of fluids, medications, blood products, or parenteral nutrition through central venous access.
- Use in patients who require central venous access for clinical management.
Clinical Applications
- Central venous access when peripheral intravenous access is inadequate or not appropriate.
- Administration of intravenous medications and fluids.
- Administration of parenteral nutrition.
- Administration of blood products or other therapies requiring central venous access.
Reported off-label uses
- Use as temporary access during selected endovascular procedures when appropriate for the catheter's size and specifications.
- Use for extended venous access beyond the labeled duration, when judged appropriate by the treating clinician.
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 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.
Practical Considerations
- The appropriate catheter size, length, number of lumens, and insertion site depend on the patient's anatomy and the intended therapy.
- Placement should use sterile technique and, when appropriate, ultrasound and fluoroscopic guidance to reduce malposition and access-related complications.
- Confirm catheter-tip position and function before use according to institutional practice.
- MRI safety and conditional-use information must be confirmed from the device labeling; do not assume the catheter is MRI safe solely because it is a central venous catheter.
- Potential complications include infection, bleeding, thrombosis, vessel injury, air embolism, catheter malposition, occlusion, and pneumothorax when a thoracic access route is used.
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.