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penumbra coil 400 ruby coil system pod system
Penumbra
Summary: The Penumbra Coil 400 Ruby Coil System POD System is a medical device used for embolization procedures. It is primarily utilized by interventional radiologists and vascular surgeons to treat vascular abnormalities and control bleeding.
FDA Clearance Information
Pathway 510K
Number K173614 ↗
Decision Date April 17, 2018
Product Code HCG
Device Class Class 2
Evidence 0 studies
The Penumbra Coil 400 Ruby Coil System POD System was cleared through the FDA 510(k) pathway on April 17, 2018. Manufactured by Penumbra, it is classified as a Class 2 device under product code HCG.
What It Is
The Penumbra Coil 400 Ruby Coil System POD System is a set of embolization coils designed to occlude blood vessels. These coils are deployed through a catheter to create a mechanical barrier within the vessel, effectively reducing or stopping blood flow. The system is particularly useful in treating aneurysms, arteriovenous malformations, and other vascular conditions where blood flow needs to be controlled.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures that require the occlusion of blood vessels, such as the treatment of cerebral aneurysms or peripheral vascular lesions. The device is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The FDA indications for the Penumbra Coil 400 Ruby Coil System POD System involve its use in embolization procedures to treat vascular abnormalities. This includes conditions like aneurysms or arteriovenous malformations where controlling blood flow is necessary.
Practical Considerations
The Penumbra Coil 400 Ruby Coil System POD System comes in various sizes to accommodate different vessel diameters. It is compatible with standard microcatheters used in embolization procedures. Clinicians should be familiar with catheter navigation techniques to ensure precise coil placement.
Frequently Asked Questions
What is the Penumbra Coil 400 Ruby Coil System POD System used for?
It is used for embolization procedures to occlude blood vessels and control blood flow in conditions like aneurysms.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for embolization procedures to treat vascular abnormalities such as aneurysms and 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.