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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 the introduction of embolization coils. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway 510K
Number K190974 ↗
Decision Date May 14, 2019
Product Code DYB
Device Class Class 2
Evidence 0 studies
The d vill introducer was cleared through the FDA 510(k) pathway on May 14, 2019. Manufactured by Numed, it is classified as a Class 2 medical device under the product code DYB.
What It Is
The d vill introducer is a specialized medical device designed to facilitate the introduction of embolization coils into the vascular system. It typically consists of a sheath and dilator system that allows for smooth and controlled access to target vessels. This device is crucial in procedures where precise delivery of embolic materials is required to occlude blood flow to specific areas, such as in the treatment of aneurysms or arteriovenous malformations.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the d vill introducer is employed in procedures that require the placement of embolization coils. These procedures are often performed in hospital settings, particularly in catheterization labs or interventional radiology suites. The device is used in patients requiring embolization for conditions such as aneurysms, vascular malformations, or to control bleeding.
Indications for Use
The FDA-cleared indications for the d vill introducer involve its use in the delivery of embolization coils. This is typically for patients who need vascular occlusion to treat aneurysms or other vascular abnormalities.
Practical Considerations
The d vill introducer comes in various sizes to accommodate different vessel diameters and is compatible with standard embolization coils. Clinicians should ensure proper sizing and compatibility with the coils being used. Familiarity with vascular anatomy and fluoroscopic guidance is essential for optimal use.
Frequently Asked Questions
What is d vill introducer used for?
The d vill introducer is used for the introduction of embolization coils into the vascular system, primarily in interventional radiology.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the d vill introducer.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils to occlude blood flow in vascular procedures.
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.