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medusa vascular plug
Endoshape
Summary: The Medusa Vascular Plug is a device used to occlude blood vessels, typically in interventional radiology or vascular surgery. It is used by clinicians to manage vascular anomalies or control bleeding.
FDA Clearance Information
Pathway 510K
Number K123696 ↗
Decision Date October 25, 2013
Product Code KRD
Device Class Class 2
Evidence 0 studies
The Medusa Vascular Plug, manufactured by Endoshape, was cleared through the FDA 510(k) pathway on October 25, 2013. It is a Class 2 medical device.
What It Is
The Medusa Vascular Plug is a medical device designed to occlude or block blood vessels. It is made from a shape-memory polymer that expands to fit the vessel, providing a secure seal. This device is used to treat vascular abnormalities by stopping blood flow to specific areas, which can help manage conditions like aneurysms or arteriovenous malformations.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Medusa Vascular Plug is employed in procedures requiring precise vascular occlusion. It is suitable for patients with conditions such as aneurysms, arteriovenous malformations, or to control bleeding during surgery. The device is typically used in hospital settings where advanced imaging and interventional procedures are performed.
Indications for Use
The FDA indications for the Medusa Vascular Plug include use in patients needing vascular occlusion. This means it is intended for individuals with conditions that require the blocking of blood flow in specific vessels, such as in the treatment of aneurysms or to prevent bleeding.
Practical Considerations
The Medusa Vascular Plug comes in various sizes to accommodate different vessel diameters. It is important to select the appropriate size for effective occlusion. Compatibility with standard delivery systems used in interventional procedures is a key consideration.
Frequently Asked Questions
What is the Medusa Vascular Plug used for?
The Medusa Vascular Plug is used to occlude blood vessels in order to manage vascular anomalies or control bleeding.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Medusa Vascular Plug.
What are the FDA-cleared indications?
The FDA-cleared indications include use for vascular occlusion in patients needing blood flow blockage for conditions like aneurysms or arteriovenous malformations.
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.