đź“‹ FDA Reference
medamicus axia rsn
Medamicus
Summary: The Medamicus Axia RSN is an embolization coil used in interventional radiology to treat vascular abnormalities. It is primarily used by interventional radiologists to prevent or control bleeding.
FDA Clearance Information
Pathway
510K
Number
K020563 ↗
Decision Date
May 21, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medamicus Axia RSN was cleared through the FDA 510(k) pathway on May 21, 2002. Manufactured by Medamicus, it is classified as a Class 2 device under product code DYB.
What It Is
The Medamicus Axia RSN is a medical device designed for embolization procedures. It consists of coils that are inserted into blood vessels to obstruct blood flow, effectively treating aneurysms or preventing hemorrhage. The device is deployed via catheter, allowing precise placement within the vascular system.
Clinical Applications
This device is commonly used in interventional radiology for procedures such as treating cerebral aneurysms or controlling gastrointestinal bleeding. It is particularly useful in settings where minimally invasive techniques are preferred, such as in hospitals with advanced radiology departments. The device is suitable for a wide range of patient populations, including those with vascular malformations or at risk of hemorrhage.
Indications for Use
The FDA-cleared indications for the Medamicus Axia RSN include use in patients requiring embolization to manage vascular abnormalities. It is intended for conditions where blood flow needs to be controlled or stopped to prevent bleeding.
Practical Considerations
The Medamicus Axia RSN comes in various sizes to accommodate different vessel diameters. It is compatible with standard catheter systems used in interventional radiology. Clinicians should be familiar with catheter navigation techniques to ensure accurate placement of the coils.
Frequently Asked Questions
What is Medamicus Axia RSN used for?
The Medamicus Axia RSN is used for embolization to treat vascular abnormalities and control bleeding.
What specialties typically use this device?
Interventional radiologists primarily use this device in procedures requiring vascular embolization.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to manage vascular abnormalities and prevent hemorrhage.
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.