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neuron support catheter system model 5f 6f
Penumbra
Summary: The Neuron Support Catheter System Model 5F 6F by Penumbra is a device used in venous stenting procedures. It was FDA cleared via the 510(k) pathway in 2007. Key evidence includes 11 studies exploring its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K070970 ↗
Decision Date
August 17, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Neuron Support Catheter System Model 5F 6F received FDA clearance through the 510(k) pathway on August 17, 2007. It is manufactured by Penumbra and classified as a Class 2 medical device under product code DQY.
What It Is
The Neuron Support Catheter System is designed to facilitate the delivery of therapeutic agents or devices to the venous system. It is primarily used in venous stenting procedures, providing support and access to targeted vascular sites.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures requiring venous access and support, such as the placement of stents in the venous system. It is particularly useful in complex vascular interventions.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as RCTs and case series, published between 2021 and 2025. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report varied outcomes, with some indicating successful venous access and stenting procedures. However, specific efficacy metrics are not detailed in the provided evidence. Further research may be needed to quantify these outcomes.
Safety Profile
Reported complications include potential adverse effects related to venous access and catheter use, though specific safety data from the provided studies are limited. Further detailed safety assessments are necessary.
Evidence Limitations
The evidence base is limited by the lack of detailed outcome and safety data in the provided studies. Further research is needed to establish comprehensive efficacy and safety profiles and to address potential gaps in the current literature.
Frequently Asked Questions
What are the clinical indications for the Neuron Support Catheter System Model 5F 6F?
The device is indicated for use in venous stenting procedures, providing support and access to targeted vascular sites.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the provided evidence, but studies suggest successful venous access and stenting procedures.
What complications have been reported?
Reported complications include potential adverse effects related to venous access and catheter use, though specific safety data are limited.
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.