đź“Š Evidence-Based Reference
Microfuse Intravenous Catheter Set
Norton Performance Plastics
Summary: The microfuse intravenous catheter set is used for intravenous therapy, primarily in venous-stent applications. Key evidence includes studies on catheter placement and infection risks.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K840240 ↗
Decision Date ?
April 17, 1984
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The microfuse intravenous catheter set was cleared by the FDA via the 510(k) pathway on April 17, 1984. It is manufactured by Norton Performance Plastics and classified as a Class 2 device.
What It Is
The microfuse intravenous catheter set is designed for intravenous access, facilitating the administration of fluids, medications, or nutrients directly into the venous system. It is commonly used in clinical settings for patients requiring venous-stent applications.
FDA-Cleared Indications
- Percutaneous catheter access to the venous system for intravenous therapy.
- Use as a catheter set for administering fluids, medications, nutrients, or other prescribed intravenous treatments.
Clinical Applications
- Establishing peripheral or other venous access for intravenous fluids.
- Administering intravenous medications or nutritional therapy.
- Providing venous access when repeated intravenous treatment is needed.
- Supporting catheter-based venous procedures when the specific catheter configuration and labeling are appropriate.
Evidence Summary
The available literature includes 10 studies, comprising randomized clinical trials and systematic reviews, conducted between 2022 and 2025. These studies explore various aspects of catheter use, including placement techniques and infection risks.
Reported Outcomes
Published studies report that the microfuse intravenous catheter set is effective in providing stable venous access for intravenous therapy. The use of ultrasound guidance in catheter placement has been shown to improve success rates and reduce complications.
Safety Profile
Reported complications include the risk of nosocomial infections, particularly due to biofilm-forming microorganisms on catheter surfaces. Proper placement and maintenance protocols are essential to minimize these risks.
Evidence Limitations
Current evidence is limited by the variability in study designs and the lack of large-scale, long-term studies. Further research is needed to fully understand the long-term safety and efficacy of the device in diverse patient populations.
Practical Considerations
- The available record does not provide the catheter diameter, length, lumen configuration, guidewire compatibility, or component materials; confirm these details in the original labeling before use.
- Use only with compatible needles, guidewires, tubing, syringes, and infusion equipment, following the manufacturer’s instructions.
- Insertion should use appropriate sterile technique and, when indicated, ultrasound or other imaging guidance.
- Potential complications include bleeding, hematoma, infection, thrombosis, vessel injury, malposition, air embolism, and catheter malfunction.
- MRI safety cannot be determined from the available FDA record. Confirm MR Safe, MR Conditional, or MR Unsafe status from the device labeling before MRI.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for microfuse intravenous catheter set?
The device is indicated for intravenous therapy in patients requiring venous-stent applications, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective venous access and improved placement success with ultrasound guidance, with a focus on reducing infection risks.
What complications have been reported?
Safety data indicate risks of nosocomial infections due to biofilm formation on catheter surfaces, highlighting the importance of proper maintenance.
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.