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the big easy y-adapter
Microvena
Summary: The Big Easy Y-Adapter is a medical device used in interventional radiology for embolization procedures. It is primarily used by specialists in vascular and interventional radiology.
FDA Clearance Information
Pathway
510K
Number
K914046 ↗
Decision Date
November 8, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Big Easy Y-Adapter, manufactured by Microvena, was cleared through the FDA 510(k) pathway on November 8, 1991. It is classified as a Class 2 device under product code DYB.
What It Is
The Big Easy Y-Adapter is a component used in embolization procedures, which are minimally invasive treatments to block blood flow to certain areas. It functions as a connector that allows for the introduction of embolization coils into the vascular system. The device is designed to facilitate the delivery of coils by providing a secure and efficient pathway.
Clinical Applications
This device is commonly used in interventional radiology, particularly in procedures aimed at treating aneurysms or stopping bleeding by embolizing blood vessels. It is typically utilized in hospital settings, where specialists perform image-guided vascular interventions. The patient population includes those with vascular abnormalities or hemorrhagic conditions requiring embolization.
Indications for Use
The FDA indications for The Big Easy Y-Adapter involve its use in embolization procedures. It is intended for patients who require vascular occlusion to treat aneurysms or control bleeding.
Practical Considerations
Clinicians should be aware of the compatibility of The Big Easy Y-Adapter with various catheter systems and embolization coils. Proper technique in connecting and securing the adapter is crucial to ensure successful embolization and patient safety.
Frequently Asked Questions
What is The Big Easy Y-Adapter used for?
It is used in embolization procedures to facilitate the delivery of coils into the vascular system.
What specialties typically use this device?
Interventional radiologists and vascular specialists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in embolization procedures to treat aneurysms or control bleeding.
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.