📋 FDA Reference
Elite Hv Radial
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 ?
510(k)
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.
FDA-Cleared Indications
- Embolization procedures requiring intentional occlusion of a blood vessel.
- Use in interventional radiology procedures when targeted vascular blood-flow control is needed.
Clinical Applications
- Catheter-based embolization of selected arteries or veins.
- Control of vascular bleeding when embolization is clinically indicated.
- Occlusion of abnormal or unwanted blood flow identified during an endovascular procedure.
Practical Considerations
- The appropriate device size and configuration depend on the target vessel, anatomy, blood-flow rate and embolization goal.
- Deployment requires catheter-based vascular access and imaging guidance, typically fluoroscopy and angiography.
- Compatibility with the planned delivery catheter or system must be confirmed in the current manufacturer instructions for use.
- Potential complications include non-target embolization, vessel injury, ischemia, bleeding at the access site, infection and device migration.
- MRI safety and the conditions for MRI use should be verified in the current manufacturer labeling; do not assume compatibility from the device name alone.
Procedures that use this 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.