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endologix afx introducer system
Endologix
Summary: The Endologix AFX Introducer System is a medical device used in vascular procedures, primarily by interventional radiologists and vascular surgeons. It facilitates the introduction of embolization coils and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K111747 ↗
Decision Date
July 12, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Endologix AFX Introducer System was cleared through the FDA 510(k) pathway on July 12, 2011. It is manufactured by Endologix and classified as a Class 2 device under product code DYB.
What It Is
The Endologix AFX Introducer System is designed to provide access to the vascular system, allowing for the delivery of embolization coils and other interventional devices. It consists of a sheath and dilator that facilitate smooth entry into blood vessels, minimizing trauma to the vessel wall. This system is particularly useful in endovascular procedures where precision and control are paramount.
Clinical Applications
This device is commonly used in procedures involving embolization, where it aids in the delivery of coils to occlude blood vessels. It is frequently utilized by interventional radiologists and vascular surgeons in hospital settings, particularly in cases involving aneurysms or arteriovenous malformations. The system is suitable for adult patients requiring endovascular intervention.
Indications for Use
The FDA-cleared indications for the Endologix AFX Introducer System include its use in facilitating the introduction of embolization coils into the vascular system. It is intended for patients who require endovascular treatment for conditions such as aneurysms or vascular malformations.
Practical Considerations
The Endologix AFX Introducer System is available in various sizes to accommodate different vessel diameters, ensuring compatibility with a range of embolization coils and other devices. Clinicians should be familiar with the technique for sheath insertion to minimize complications and ensure optimal device performance.
Frequently Asked Questions
What is the Endologix AFX Introducer System used for?
It is used to facilitate the introduction of embolization coils and other devices into the vascular system during endovascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the introduction of embolization coils into the vascular system for treating conditions like aneurysms.
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.