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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, typically in the treatment of aneurysms. It is primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K142513 ↗
Decision Date
November 13, 2014
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Barricade Embolization Coil System was cleared through the FDA's 510(k) pathway on November 13, 2014. It is manufactured by Blockade Medical and classified as a Class 2 device.
What It Is
The Barricade Embolization Coil System is designed to occlude or block blood flow in targeted vessels. It consists of a series of coils that are deployed into a blood vessel to create a physical barrier, promoting clot formation and vessel occlusion. 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 to treat cerebral aneurysms and other vascular abnormalities. It is typically employed in hospital settings, particularly in catheterization labs or operating rooms. The patient population includes individuals with diagnosed aneurysms or vascular malformations, often requiring precise and minimally invasive intervention.
Indications for Use
The Barricade Embolization Coil System is indicated for use in patients who require occlusion of blood vessels, such as those with cerebral aneurysms. It is intended to prevent blood flow into abnormal vascular structures, thereby reducing the risk of complications like rupture.
Practical Considerations
The device comes 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 endovascular techniques to ensure proper deployment and positioning of the coils.
Frequently Asked Questions
What is the Barricade Embolization Coil System used for?
It is used to occlude blood vessels, primarily in the treatment of cerebral aneurysms.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for the occlusion of blood vessels, such as in the treatment of cerebral 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.