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modification to medamicus axia rsn
Medamicus
Summary: The Modification to Medamicus Axia RSN is an embolization coil used in interventional radiology to treat vascular abnormalities. It is primarily used by interventional radiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K022689 ↗
Decision Date
August 23, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on August 23, 2002, by Medamicus. It is classified as a Class 2 medical device under product code DYB.
What It Is
The Modification to Medamicus Axia RSN is an embolization coil designed to occlude blood vessels. It works by being delivered via a catheter to the target site, where it expands and induces clot formation, effectively blocking blood flow. This device is used to treat conditions such as aneurysms or arteriovenous malformations.
Clinical Applications
This device is commonly used in interventional radiology for procedures requiring vascular embolization. It is particularly useful in treating patients with cerebral aneurysms or other vascular malformations. The device is typically used in hospital settings, often in specialized radiology departments or catheterization labs.
Indications for Use
The FDA indicates this device for use in embolization procedures to treat vascular abnormalities. It is suitable for patients with conditions like aneurysms or arteriovenous malformations that require occlusion of blood vessels.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters. It is compatible with standard delivery catheters used in embolization procedures. Clinicians should be familiar with catheter-based delivery techniques to ensure proper placement and deployment.
Frequently Asked Questions
What is the Modification to Medamicus Axia RSN used for?
It is used for embolization procedures to occlude blood vessels in conditions like aneurysms and arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists primarily use this device in hospital settings, particularly in radiology departments or catheterization labs.
What are the FDA-cleared indications?
The device is indicated for embolization procedures to treat vascular abnormalities such as aneurysms and arteriovenous malformations.
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.