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d vill introducer
Numed
Summary: The d vill introducer by Numed is a medical device used primarily in interventional radiology for embolization procedures. It is designed for use by clinicians specializing in vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K171206 ↗
Decision Date
October 20, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The d vill introducer was cleared through the FDA 510(k) pathway on October 20, 2017. Manufactured by Numed, it is classified as a Class 2 device under product code DYB.
What It Is
The d vill introducer is a specialized medical device used to facilitate the introduction of embolization coils into the vascular system. It is designed to provide a stable and controlled pathway for the delivery of these coils, which are used to occlude blood vessels. This device is crucial in procedures where precise placement of embolization materials is necessary to achieve therapeutic outcomes.
Clinical Applications
Commonly used in interventional radiology, the d vill introducer is employed in procedures such as the treatment of aneurysms or arteriovenous malformations. It is particularly useful in settings where vascular access and precise delivery of embolization coils are required, such as in hospitals or specialized vascular clinics. The device is suitable for use in adult and pediatric populations, depending on the clinical scenario.
Indications for Use
The FDA indications for the d vill introducer involve its use in embolization procedures, where it aids in the delivery of coils to occlude blood vessels. This is particularly applicable in conditions requiring the reduction of blood flow to specific areas, such as in the treatment of aneurysms.
Practical Considerations
The d vill introducer comes in various sizes to accommodate different vascular anatomies and is compatible with standard embolization coils. Clinicians should ensure proper sizing and technique to optimize outcomes and minimize complications during procedures.
Frequently Asked Questions
What is d vill introducer used for?
The d vill introducer is used to facilitate the delivery of embolization coils in vascular procedures, particularly in interventional radiology.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use the d vill introducer in procedures requiring vascular access and embolization.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to deliver coils for occluding blood vessels, 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.