đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use during vascular embolization procedures.
- Use to facilitate the introduction and delivery of embolization coils through a catheter system.
- Use when vascular occlusion is required as part of an embolization treatment.
Clinical Applications
- Delivery of embolization coils during image-guided vascular procedures.
- Vascular occlusion for treatment of selected aneurysms or pseudoaneurysms.
- Embolization to control bleeding from selected blood vessels.
- Adjunctive connection between catheter components during embolization.
Practical Considerations
- Confirm that the adapter is compatible with the catheter, guidewire, coil-delivery system and other procedural components before use.
- Inspect the adapter and connections for damage, leaks or poor fit; secure all connections before introducing embolic material.
- Use only according to the current manufacturer instructions for use and the requirements of the embolization system.
- The available record does not provide specific device dimensions, working pressure limits or size options; consult the product labeling or institutional inventory information.
- MRI safety status is not established in the information provided. Do not assume the device is MR Safe or MR Conditional without current manufacturer labeling; if retained, assess all connected or implanted components separately.
Procedures that use this device
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.