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afx introducer system
Endologix
Summary: The AFX Introducer System by Endologix is a medical device used primarily in vascular procedures to facilitate the introduction of catheters or other devices. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K110090 ↗
Decision Date
May 26, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The AFX Introducer System was cleared via the FDA 510(k) pathway on May 26, 2011. 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 assist in the insertion of catheters or other interventional devices into the vascular system. It provides a stable and secure access point, minimizing trauma to the vessel and ensuring precise device placement. This system is particularly useful in procedures requiring the introduction of embolization coils or other vascular devices.
Clinical Applications
The AFX Introducer System is commonly used in endovascular procedures, such as embolization, where precise and stable access to the vascular system is critical. It is frequently utilized in interventional radiology and vascular surgery settings, particularly for patients requiring treatment for aneurysms or other vascular abnormalities. The device is suitable for use in both elective and emergency procedures.
Indications for Use
The FDA indications for the AFX Introducer System include its use in facilitating the introduction of devices into the vascular system. It is intended for patients requiring endovascular interventions, such as those with vascular anomalies or requiring embolization therapy.
Practical Considerations
The AFX Introducer System is available in various sizes to accommodate different vessel diameters, ensuring compatibility with a wide range of catheters and devices. Clinicians should be familiar with the specific insertion techniques and ensure proper sizing to minimize complications.
Frequently Asked Questions
What is the AFX Introducer System used for?
The AFX Introducer System is used to facilitate the introduction of catheters or other devices into the vascular system during endovascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the AFX Introducer System in their procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of devices into the vascular system, particularly in procedures like embolization.
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.