đź“‹ FDA Reference
siege vascular plug svp2 5-0 021 siege vascular plug svp4-0 021 siege vascular plug svp6-0 027
Merit Medical Systems
Summary: The Siege Vascular Plug is a medical device used to occlude blood vessels in interventional radiology and vascular surgery. It is primarily used by specialists in these fields to manage vascular conditions.
FDA Clearance Information
Pathway 510K
Number K240261 ↗
Decision Date May 2, 2024
Product Code KRD
Device Class Class 2
Evidence 0 studies
The Siege Vascular Plug was cleared through the FDA 510k pathway on May 2, 2024. Manufactured by Merit Medical Systems, it is classified as a Class 2 device.
What It Is
The Siege Vascular Plug is a device designed to occlude or block blood vessels. It is typically used in minimally invasive procedures to control blood flow in specific areas, preventing bleeding or redirecting blood flow. The device is deployed using a catheter and expands to fit the vessel, creating a secure seal.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery to treat conditions such as arteriovenous malformations, aneurysms, or to control bleeding. It is suitable for use in hospitals and specialized clinics, often involving patients with complex vascular conditions requiring precise intervention.
Indications for Use
The Siege Vascular Plug is indicated for use in patients who require occlusion of blood vessels. This can include managing abnormal blood flow or preventing hemorrhage in various vascular conditions.
Practical Considerations
The Siege Vascular Plug comes in different sizes to accommodate various vessel diameters. It is compatible with standard catheter systems and requires careful imaging guidance for accurate placement. Clinicians should be familiar with vascular anatomy and catheterization techniques.
Frequently Asked Questions
What is the Siege Vascular Plug used for?
The Siege Vascular Plug is used to occlude blood vessels in order to control bleeding or redirect blood flow in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for the occlusion of blood vessels to manage abnormal blood flow or prevent hemorrhage.
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.