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Neuron Support Catheter System Model 5f 6f
Product: Neuron — all models and sizes
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 ?
510(k)
Number ?
K070970 ↗
Decision Date ?
August 17, 2007
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use to provide access to the vascular system.
- Delivery of therapeutic agents or other medical devices through the vascular system, when used according to the cleared labeling.
- Use in venous interventions requiring catheter support and access, where consistent with the device's FDA-cleared labeling.
Clinical Applications
- Providing catheter support during percutaneous venous procedures.
- Facilitating delivery of another catheter, device, or therapeutic agent to a targeted venous location.
- Supporting endovascular treatment of selected venous lesions when the catheter is used according to its labeling.
- Providing access during venous stent placement when compatible with the planned procedure and device instructions.
Reported off-label uses
- Use as an access or support catheter in vascular procedures outside the specific venous applications described in the labeling may occur in clinical practice, but requires physician judgment and is not necessarily FDA-cleared for that purpose.
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 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.
Practical Considerations
- The system is identified in 5F and 6F configurations; the selected size must match the anatomy, access sheath, guidewire, and device being delivered.
- Use requires percutaneous vascular access and imaging guidance, commonly fluoroscopy, with the access site and anticoagulation plan determined by the treating team.
- Confirm compatibility with guidewires, stents, thrombectomy systems, contrast agents, and other devices before use.
- Review the current manufacturer instructions for contraindications, warnings, catheter preparation, maximum injection pressure, and handling limits.
- MRI safety should not be assumed from the FDA record alone; check the current device labeling and the complete procedure setup before MRI.
Procedures that use this device
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.