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exonox percutaneous introducer system w hemostasi
Exonix Research
Summary: The Exonox Percutaneous Introducer System is a medical device used for introducing embolization coils into the vascular system. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K923681 ↗
Decision Date
January 21, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Exonox Percutaneous Introducer System was cleared through the FDA 510(k) pathway on January 21, 1993. Manufactured by Exonix Research, it is classified as a Class 2 device under product code DYB.
What It Is
The Exonox Percutaneous Introducer System is designed to facilitate the insertion of embolization coils into the vascular system. It consists of a sheath and dilator that allow for smooth and controlled access to blood vessels, minimizing trauma to the vessel wall. This system is crucial in procedures requiring precise placement of coils to occlude blood flow to specific areas.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures such as embolization of aneurysms or arteriovenous malformations. It is particularly useful in settings where minimally invasive techniques are preferred, such as in outpatient or hospital-based catheterization labs. The patient population includes those with vascular abnormalities requiring embolization.
Indications for Use
The FDA indications for the Exonox system involve its use in delivering embolization coils to treat conditions like aneurysms or vascular malformations. It is intended for patients needing targeted vascular occlusion.
Practical Considerations
The Exonox system is available in various sizes to accommodate different vessel diameters. It is compatible with standard embolization coils and requires familiarity with percutaneous techniques for optimal use. Clinicians should ensure proper sizing and technique to minimize complications.
Frequently Asked Questions
What is the Exonox Percutaneous Introducer System used for?
It is used for introducing embolization coils into the vascular system to occlude blood flow in targeted areas.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for delivering embolization coils to treat vascular 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.