📋 FDA Reference
Vygon Micro-Access Safety Introducer Kit
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitates the introduction of catheters or other devices into the vascular system.
- Provides percutaneous vascular access for procedures requiring placement of intravascular catheters or devices.
Clinical Applications
- Obtaining vascular access before diagnostic angiography.
- Obtaining vascular access before endovascular catheter-based treatment.
- Introducing catheters or other intravascular devices through a percutaneous access site.
Practical Considerations
- Available sizes and configurations should be selected according to the target vessel, access technique, and catheter or device size.
- The kit is intended for use by trained clinicians familiar with percutaneous vascular access and the Seldinger technique.
- Ultrasound and fluoroscopic guidance may be used depending on the access site and procedure.
- Inspect the needle, guidewire, sheath, and packaging before use; follow the current product instructions for use.
- MRI safety depends on the specific kit components and whether they remain in the patient. Confirm the exact model and labeling before MRI; temporary access components are generally removed after the procedure.
Procedures that use this device
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.