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barricade embolization coil system
Blockade Medical
Summary: The Barricade Embolization Coil System is a medical device used to occlude blood vessels in various clinical scenarios, primarily by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K140104 ↗
Decision Date
February 13, 2014
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Barricade Embolization Coil System was cleared through the FDA 510(k) pathway on February 13, 2014, by Blockade Medical. It is classified as a Class 2 device under product code HCG.
What It Is
The Barricade Embolization Coil System is a device designed to occlude blood vessels by deploying coils into the vascular system. These coils induce clotting, which helps to block blood flow to specific areas, such as aneurysms or abnormal vascular formations. The system is typically delivered via a catheter, allowing for precise placement within the vascular system.
Clinical Applications
This device is commonly used in the treatment of cerebral aneurysms and other vascular abnormalities. Interventional radiologists and neurosurgeons often use it in hospital settings, particularly in the interventional suite or operating room. It is suitable for patients requiring endovascular intervention to prevent hemorrhage or to manage vascular malformations.
Indications for Use
The FDA indications for the Barricade Embolization Coil System include the occlusion of blood vessels in the peripheral and neurovascular systems. It is intended for patients with conditions such as aneurysms or other vascular abnormalities that require embolization.
Practical Considerations
The Barricade Embolization Coil System comes in various sizes to accommodate different vessel diameters and anatomical locations. It is compatible with standard microcatheters used in endovascular procedures. Clinicians should be familiar with coil deployment techniques and ensure proper coil sizing to achieve optimal occlusion.
Frequently Asked Questions
What is the Barricade Embolization Coil System used for?
It is used to occlude blood vessels in the treatment of aneurysms and other vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the occlusion of blood vessels in the peripheral and neurovascular systems.
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.