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venous m a internal jugular kit
Norton Performance Plastics
Summary: The venous m a internal jugular kit by Norton Performance Plastics is a Class 2 medical device used for embolization-coils. It was FDA cleared via the 510k pathway. Key evidence includes studies on collapsibility indices and preventive strategies for complications.
FDA Clearance Information
Pathway
510K
Number
K800620 ↗
Decision Date
April 24, 1980
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The venous m a internal jugular kit was cleared by the FDA on April 24, 1980, via the 510k pathway. Manufactured by Norton Performance Plastics, it is classified as a Class 2 device under product code DYB.
What It Is
The venous m a internal jugular kit is designed for use in procedures involving embolization-coils, particularly in the internal jugular vein. It is intended for clinicians managing venous access and related interventions.
Clinical Applications
This device is commonly used in clinical scenarios requiring venous access through the internal jugular vein, such as in the placement of central venous catheters or during embolization procedures.
Evidence Summary
The available literature includes five studies, primarily focusing on ultrasonographic evaluations and preventive strategies for complications. These studies are sourced from clinical trial registries and span various clinical contexts.
Reported Outcomes
Published studies report on the utility of ultrasonographic evaluation of vein collapsibility indices in predicting clinical outcomes. However, specific efficacy findings related to the venous m a internal jugular kit are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with central venous catheterization, though specific adverse events related to this device are not detailed in the provided studies.
Evidence Limitations
The evidence provided lacks specific data on the efficacy and safety of the venous m a internal jugular kit. Further research is needed to establish detailed clinical outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for venous m a internal jugular kit?
The device is indicated for use in procedures involving embolization-coils, particularly in the internal jugular vein.
What outcomes have been reported in clinical studies?
Studies report on ultrasonographic evaluations of vein collapsibility indices, but specific outcomes for this device are not detailed.
What complications have been reported?
Safety data from the evidence is limited, with general risks associated with central venous catheterization noted.
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.