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nfocus neuromedical echo distal access catheter
Nfocus Neuromedical
Summary: The Echo Distal Access Catheter by Nfocus Neuromedical is a medical device used for vascular access in neurointerventional procedures. It is primarily utilized by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K090918 ↗
Decision Date
July 30, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Echo Distal Access Catheter was cleared through the FDA 510k pathway on July 30, 2009. It is manufactured by Nfocus Neuromedical and classified as a Class 2 device under product code DQY.
What It Is
The Echo Distal Access Catheter is a specialized catheter designed to facilitate access to the distal vasculature during neurointerventional procedures. It features a flexible design that allows navigation through complex vascular anatomy, providing support for the delivery of therapeutic devices. This catheter is integral in procedures requiring precise vascular access, such as in the treatment of cerebral aneurysms or arteriovenous malformations.
Clinical Applications
This catheter is commonly used in neurointerventional procedures, particularly within the specialties of interventional radiology and neurosurgery. It is employed in hospital settings, especially in the neurointerventional suite, to facilitate the treatment of conditions like stroke, aneurysms, and other cerebrovascular disorders. The device is suitable for adult patients requiring endovascular therapy.
Indications for Use
The FDA-cleared indications for the Echo Distal Access Catheter include its use in gaining access to the distal vasculature in neurointerventional procedures. It is intended for patients who require endovascular treatment of cerebrovascular conditions.
Practical Considerations
The Echo Distal Access Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard neurointerventional equipment and requires careful handling to navigate tortuous vascular pathways effectively.
Frequently Asked Questions
What is the Echo Distal Access Catheter used for?
It is used for gaining access to the distal vasculature during neurointerventional procedures, such as treating cerebral aneurysms or arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device in neurointerventional procedures.
What are the FDA-cleared indications?
The catheter is indicated for use in accessing the distal vasculature in neurointerventional procedures for patients requiring endovascular treatment of cerebrovascular conditions.
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.