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modification to ivs introducer set model 1003
Integrated Vascular Systems
Summary: The IVS Introducer Set Model 1003 is a medical device used for vascular access, particularly in procedures requiring embolization coils. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K031583 ↗
Decision Date
June 16, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The IVS Introducer Set Model 1003 was cleared through the FDA 510(k) pathway on June 16, 2003. Manufactured by Integrated Vascular Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The IVS Introducer Set Model 1003 is a specialized tool designed to facilitate the introduction of embolization coils into the vascular system. It typically includes a sheath and dilator, allowing for smooth and controlled access to blood vessels. This device is crucial in minimally invasive procedures, ensuring that embolization materials are accurately delivered to the target site.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is essential in procedures where embolization coils are deployed to treat conditions such as aneurysms or to block blood flow to certain areas, such as tumors. The device is suitable for adult patients requiring endovascular interventions and is often used in hospital catheterization labs.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring the introduction of embolization coils. It is designed for patients needing vascular interventions, often to manage abnormal blood flow or to occlude blood vessels.
Practical Considerations
Clinicians should consider the compatibility of the introducer set with the specific embolization coils being used. The device is available in various sizes to accommodate different vessel diameters. Proper technique in insertion and handling is crucial to minimize vascular trauma.
Frequently Asked Questions
What is the IVS Introducer Set Model 1003 used for?
It is used for introducing embolization coils into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring the introduction of embolization coils to manage blood flow in vascular interventions.
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.