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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 typically used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K151760 ↗
Decision Date
July 27, 2015
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Barricade Embolization Coil System was cleared through the FDA 510(k) pathway on July 27, 2015. Manufactured by Blockade Medical, it is classified as a Class II device under product code HCG.
What It Is
The Barricade Embolization Coil System is designed to occlude blood vessels by deploying coils that induce clot formation, effectively blocking blood flow. This system is used in endovascular procedures to treat conditions such as aneurysms or arteriovenous malformations. The coils are delivered via a catheter and can be precisely positioned to achieve optimal occlusion.
Clinical Applications
This device is commonly used in interventional radiology and neurosurgery for the treatment of cerebral aneurysms and other vascular abnormalities. It is particularly useful in minimally invasive procedures where precise embolization is required. The system is suitable for use in both adult and pediatric populations, depending on the clinical scenario.
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 vascular malformations that require embolization.
Practical Considerations
The Barricade Embolization Coil System is available in various sizes to accommodate different vessel diameters and anatomical locations. It is important to ensure compatibility with the delivery catheter and to follow precise deployment techniques to achieve effective occlusion.
Frequently Asked Questions
What is the Barricade Embolization Coil System used for?
It is used to occlude blood vessels during embolization procedures, often to treat aneurysms or vascular malformations.
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.