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afx introducer system
Endologix
Summary: The AFX Introducer System by Endologix is a medical device used primarily in vascular procedures for the introduction of embolization coils. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K120212 ↗
Decision Date
February 9, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The AFX Introducer System was cleared through the FDA 510k pathway on February 9, 2012. Manufactured by Endologix, it is classified as a Class 2 device under product code DYB.
What It Is
The AFX Introducer System is a medical device designed to facilitate the delivery of embolization coils into the vascular system. It consists of a sheath and a dilator, allowing for smooth insertion and navigation within blood vessels. This system is crucial in procedures requiring precise placement of coils to occlude blood flow in targeted areas, such as aneurysms or arteriovenous malformations.
Clinical Applications
The AFX Introducer System is commonly used in interventional radiology and vascular surgery settings. It is employed in endovascular procedures where embolization is needed to treat conditions like aneurysms, arteriovenous malformations, or to control bleeding. The device is suitable for adult patients requiring minimally invasive vascular interventions.
Indications for Use
The FDA-cleared indications for the AFX Introducer System involve its use in the delivery of embolization coils to occlude blood vessels. It is intended for patients with vascular conditions requiring embolization, such as aneurysms or abnormal blood vessel formations.
Practical Considerations
The AFX Introducer System is available in various sizes to accommodate different vessel diameters. It is compatible with standard embolization coils and requires careful handling to ensure accurate placement. Clinicians should be familiar with vascular anatomy and endovascular techniques when using this device.
Frequently Asked Questions
What is the AFX Introducer System used for?
The AFX Introducer System is used for the delivery of embolization coils in vascular procedures to occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the AFX Introducer System.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils to occlude blood vessels in patients with conditions like aneurysms or 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.