đź“‹ FDA Reference
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Lepu Medical Technology (Bejing)
Summary: The Brilliant Introducer Kit is a medical device used for introducing embolization coils into the vasculature. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K140768 ↗
Decision Date
November 25, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Brilliant Introducer Kit by Lepu Medical Technology was cleared via the FDA 510k pathway on November 25, 2014. It is a Class 2 medical device under product code DYB.
What It Is
The Brilliant Introducer Kit is a set of medical tools designed to facilitate the introduction of embolization coils into blood vessels. It typically includes a sheath and dilator system that allows for smooth and precise placement of coils, which are used to occlude blood vessels and control bleeding. The device is engineered to minimize trauma to the vessel wall during insertion.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for procedures requiring vascular embolization. It is particularly useful in treating conditions such as aneurysms, arteriovenous malformations, and other vascular abnormalities. The kit is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The FDA-cleared indications for the Brilliant Introducer Kit involve its use in embolization procedures, where it helps deliver coils to occlude abnormal blood vessels. This is beneficial in managing conditions like aneurysms or controlling bleeding in trauma cases.
Practical Considerations
The Brilliant Introducer Kit is available in various sizes to accommodate different vessel diameters. It is compatible with standard embolization coils and requires careful handling to ensure proper placement. Clinicians should be trained in vascular access techniques to use this device effectively.
Frequently Asked Questions
What is the Brilliant Introducer Kit used for?
It is used for introducing embolization coils into blood vessels to occlude them, often in the treatment of aneurysms or vascular malformations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in procedures involving vascular embolization.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to deliver coils for occluding blood vessels in conditions like aneurysms.
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.