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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 during embolization procedures. It is primarily used by interventional radiologists and neurosurgeons to treat aneurysms and other vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K123338 ↗
Decision Date
March 28, 2013
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Barricade Embolization Coil System was cleared through the FDA 510(k) pathway on March 28, 2013. Manufactured 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 minimally invasive device designed to occlude blood vessels. It consists of coils that are delivered through a catheter to the target site, where they expand and create a scaffold to induce clot formation. This device is particularly useful in treating cerebral aneurysms by preventing blood flow into the aneurysm sac, thereby reducing the risk of rupture.
Clinical Applications
This device is commonly used in interventional radiology and neurosurgery for the treatment of intracranial aneurysms and other vascular abnormalities. It is typically utilized in hospital settings, particularly in the interventional suite or operating room. Patients who benefit from this device often have conditions that pose a risk of hemorrhage, such as brain aneurysms or arteriovenous 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 used in patients with aneurysms or other conditions where blood flow needs to be controlled or stopped.
Practical Considerations
The Barricade Embolization Coil System is available in various sizes to accommodate different vessel diameters and anatomical locations. It is compatible with standard microcatheters used in embolization procedures. Clinicians should be skilled in catheter-based interventions and familiar with the anatomy of the target vessels.
Frequently Asked Questions
What is the Barricade Embolization Coil System used for?
It is used to occlude blood vessels during embolization procedures, particularly for treating aneurysms and vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly 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, such as in the treatment of 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.