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Neuron Select Catheter Size 070
Product: Neuron — all models and sizes
Summary: The Neuron Select Catheter 070 by Penumbra is a medical device used for vascular access in neurovascular procedures. It is primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K083125 ↗
Decision Date ?
November 21, 2008
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Neuron Select Catheter 070 was cleared by the FDA through the 510(k) pathway on November 21, 2008. It is manufactured by Penumbra and classified as a Class 2 device under product code DQY.
What It Is
The Neuron Select Catheter 070 is a specialized catheter designed for accessing the neurovascular system. It features a flexible design to navigate the complex vasculature of the brain. This catheter is used to facilitate the delivery of therapeutic devices or medications directly to the site of vascular lesions or blockages.
FDA-Cleared Indications
- Percutaneous catheter access to blood vessels for diagnostic or therapeutic procedures, consistent with FDA product code DQY.
- Use by trained clinicians when catheter-based vascular access is required for an indicated procedure.
Clinical Applications
- Establishing percutaneous vascular access for catheter-based interventions.
- Providing a conduit for the introduction or exchange of compatible guidewires, catheters, or other interventional devices.
- Supporting endovascular procedures when the catheter size and configuration are appropriate for the patient's vascular anatomy.
Reported off-label uses
- Use as an access or support catheter in selected neurointerventional procedures, including treatment of cerebral aneurysms, arteriovenous malformations, or ischemic stroke, when not specifically covered by the device labeling.
- Use in selected peripheral or venous interventions, such as thrombectomy or venous stenting, when the catheter is technically compatible and the treating clinician determines that off-label use is appropriate.
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.
Practical Considerations
- Confirm the catheter's inner and outer diameter, usable length, distal shape, and compatibility with the guidewire, sheath, and other devices before use.
- Use fluoroscopic or other appropriate imaging guidance and advance the catheter gently; resistance can indicate spasm, tortuosity, stenosis, or a size mismatch.
- Review the current manufacturer instructions for use for contraindications, warnings, flushing, preparation, and device-specific handling requirements.
- MRI safety status should be confirmed in the current labeling; do not assume that a catheter or any retained component is MR Safe or MR Conditional.
- This is a single-use sterile catheter unless the current labeling states otherwise. Do not reuse or resterilize it, and discard it after the procedure according to institutional policy.
Procedures that use this device
Frequently Asked Questions
What is the Neuron Select Catheter 070 used for?
It is used for vascular access in neurointerventional procedures, such as treating aneurysms or strokes.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring vascular access for neurointerventional procedures involving the brain's blood vessels.
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.