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Vascular Solutions
Summary: The VSI Micro-Introducer Sets are used in vascular procedures to facilitate the introduction of catheters or other devices. They are primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K101604 ↗
Decision Date
January 24, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The VSI Micro-Introducer Sets by Vascular Solutions were cleared via the FDA 510(k) pathway on January 24, 2011. They are classified as Class 2 devices under product code DYB.
What It Is
The VSI Micro-Introducer Sets are medical devices designed to assist in the insertion of catheters or other interventional tools into the vascular system. These sets include a sheath and dilator, which help in creating a stable pathway for device introduction. The regular stiffen models provide enhanced control and stability during procedures.
Clinical Applications
These devices are commonly used in interventional radiology and cardiology for procedures such as embolization, where precise catheter placement is crucial. They are used in hospital settings, particularly in catheterization labs, and are suitable for adult patients undergoing vascular interventions.
Indications for Use
The FDA-cleared indications for these devices include facilitating the introduction of catheters into the vascular system. They are used in patients requiring vascular access for diagnostic or therapeutic procedures.
Practical Considerations
The VSI Micro-Introducer Sets come in various sizes to accommodate different patient anatomies and procedural needs. They are compatible with a range of catheters and are designed for ease of use, minimizing trauma to the vessel during insertion.
Frequently Asked Questions
What is VSI Micro-Introducer Sets used for?
They are used to facilitate the introduction of catheters or other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use these devices during vascular procedures.
What are the FDA-cleared indications?
The devices are indicated for facilitating the introduction of catheters into the vascular system for diagnostic or therapeutic purposes.
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.