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valvokit
Novamed Products
Summary: The Valvokit is a medical device used in embolization procedures to treat vascular abnormalities. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K854831 ↗
Decision Date
March 31, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Valvokit was cleared through the FDA 510(k) pathway on March 31, 1986. Manufactured by Novamed Products, it is classified as a Class 2 device under product code DYB.
What It Is
The Valvokit is a device designed for use in embolization procedures, which involve the intentional occlusion of blood vessels. It typically includes embolization coils that are deployed to block blood flow to specific areas, such as aneurysms or tumors, to prevent bleeding or reduce blood supply to abnormal tissues. This device is crucial in minimally invasive procedures and helps in reducing procedural risks and recovery time.
Clinical Applications
The Valvokit is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat conditions such as aneurysms, arteriovenous malformations, and certain types of tumors by occluding their blood supply. The device is suitable for use in both inpatient and outpatient settings, often involving patients with vascular abnormalities or those requiring pre-surgical embolization.
Indications for Use
The FDA indications for the Valvokit include its use in embolization procedures to occlude blood vessels. This is particularly relevant for patients with vascular abnormalities like aneurysms or tumors that require reduced blood flow.
Practical Considerations
The Valvokit comes in various sizes to accommodate different vessel diameters and clinical needs. It is compatible with standard catheter systems used in interventional procedures. Clinicians should be familiar with the deployment technique to ensure proper placement and effectiveness.
Frequently Asked Questions
What is Valvokit used for?
Valvokit is used for embolization procedures to occlude blood vessels, often to treat aneurysms or tumors.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Valvokit.
What are the FDA-cleared indications?
The Valvokit is indicated for use in embolization procedures to occlude blood vessels in patients with vascular abnormalities.
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.