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elite hv radial
Galt Medical
Summary: The elite hv radial is a medical device used for embolization procedures, primarily by interventional radiologists. It is designed to aid in the occlusion of blood vessels to treat various conditions.
FDA Clearance Information
Pathway
510K
Number
K173287 ↗
Decision Date
December 21, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The elite hv radial received FDA clearance through the 510(k) pathway on December 21, 2017. Manufactured by Galt Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The elite hv radial is a specialized embolization coil used in interventional radiology. It works by being deployed into a blood vessel to create an obstruction, effectively stopping blood flow to a targeted area. This device is particularly useful in procedures requiring precise vascular occlusion, such as treating aneurysms or controlling bleeding.
Clinical Applications
Commonly used in interventional radiology, the elite hv radial is employed in procedures like embolization of aneurysms, arteriovenous malformations, and controlling hemorrhages. It is suitable for use in hospital settings, particularly in catheterization labs, and is often used in adult and pediatric patient populations requiring vascular intervention.
Indications for Use
The elite hv radial is indicated for use in embolization procedures, which involve the intentional blockage of blood vessels. It is suitable for patients with conditions such as aneurysms or vascular malformations where blood flow needs to be controlled or stopped.
Practical Considerations
The elite hv radial is available in various sizes to accommodate different vessel diameters and clinical needs. It is compatible with standard embolization delivery systems. Clinicians should be proficient in catheter-based techniques to ensure proper deployment and positioning of the device.
Frequently Asked Questions
What is elite hv radial used for?
The elite hv radial is used for embolization procedures to occlude blood vessels in conditions like aneurysms or vascular malformations.
What specialties typically use this device?
Interventional radiologists primarily use this device in hospital settings, especially in catheterization labs.
What are the FDA-cleared indications?
The device is cleared for use in embolization procedures to block blood vessels in various clinical scenarios.
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.