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vygon micro-access safety introducer kit
Vygon
Summary: The Vygon Micro-Access Safety Introducer Kit is a medical device used for vascular access, primarily by interventional radiologists and cardiologists. It is designed to facilitate the introduction of catheters or other devices into the vascular system safely.
FDA Clearance Information
Pathway
510K
Number
K051248 ↗
Decision Date
October 27, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Vygon Micro-Access Safety Introducer Kit was cleared through the FDA 510k pathway on October 27, 2005. Manufactured by Vygon, it is classified as a Class 2 device under product code DYB.
What It Is
The Vygon Micro-Access Safety Introducer Kit is a specialized medical device used to gain access to the vascular system. It typically includes a needle, guidewire, and introducer sheath, allowing for the safe and efficient insertion of catheters or other medical devices. This kit is particularly useful in procedures requiring precise vascular access, minimizing the risk of complications such as vessel trauma or bleeding.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and catheter placement. It is suitable for use in hospital settings, particularly in catheterization labs or interventional suites. The device is often used in adult and pediatric patients requiring vascular access for diagnostic or therapeutic interventions.
Indications for Use
The FDA-cleared indications for the Vygon Micro-Access Safety Introducer Kit include facilitating the introduction of catheters or other devices into the vascular system. It is intended for patients needing vascular access for procedures like angiography or embolization.
Practical Considerations
The kit typically comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires, and clinicians should be familiar with the Seldinger technique for safe and effective use.
Frequently Asked Questions
What is the Vygon Micro-Access Safety Introducer Kit used for?
It is used for gaining vascular access to facilitate the introduction of catheters or other medical devices into the vascular system.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings, particularly in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters or other devices into the vascular system for procedures like angiography and embolization.
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.