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vsi micro-introducer kit
Vascular Solutions
Summary: The VSI Micro-Introducer Kit by Vascular Solutions is a medical device used primarily for vascular access in interventional radiology and cardiology. It is utilized by clinicians to facilitate the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K180913 ↗
Decision Date
May 9, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The VSI Micro-Introducer Kit was cleared through the FDA 510(k) pathway on May 9, 2018. Manufactured by Vascular Solutions, it is classified as a Class 2 device under product code DYB.
What It Is
The VSI Micro-Introducer Kit is a medical device designed to aid in the insertion of catheters and other devices into the vascular system. It typically includes a sheath, dilator, and guidewire, which work together to provide a safe and effective means of gaining vascular access. This device is particularly useful in procedures requiring precise catheter placement, such as angiography, embolization, and other endovascular interventions.
Clinical Applications
Clinically, the VSI Micro-Introducer Kit is used in settings such as interventional radiology and cardiology. It is commonly employed in procedures like embolization, where precise access to the vascular system is crucial. The device is suitable for adult and pediatric patients requiring vascular interventions, and it is often used in hospitals and specialized outpatient centers.
Indications for Use
The FDA has cleared this device for use in procedures that require vascular access, such as the placement of embolization coils. It is intended for patients needing endovascular interventions to treat conditions like aneurysms or arteriovenous malformations.
Practical Considerations
The VSI Micro-Introducer Kit is available in various sizes to accommodate different patient anatomies and procedural requirements. Compatibility with a range of catheters and guidewires is a key feature, and clinicians should be familiar with the technique of using micro-introducers to ensure successful vascular access.
Frequently Asked Questions
What is the VSI Micro-Introducer Kit used for?
The VSI Micro-Introducer Kit is used for gaining vascular access to facilitate the introduction of catheters and other devices into the vascular system.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is cleared for use in procedures requiring vascular access, such as the placement of embolization coils.
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.