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ivs introducer set model 1003
Integrated Vascular Systems
Summary: The IVS Introducer Set Model 1003 is a medical device used primarily for vascular access in embolization procedures. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K030723 ↗
Decision Date
April 3, 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 April 3, 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 medical device designed to facilitate the introduction of embolization coils into the vascular system. It consists of a sheath and dilator that provide a conduit for the safe and efficient delivery of therapeutic devices into blood vessels. This device is essential in procedures requiring precise vascular access and manipulation.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the IVS Introducer Set Model 1003 is employed in procedures such as the embolization of aneurysms or arteriovenous malformations. It is suitable for use in both hospital and outpatient settings, catering to adult and pediatric patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device include its use in procedures that require the introduction of embolization coils into the vascular system. It is intended for patients with conditions that necessitate embolization to prevent or control bleeding or to occlude blood vessels.
Practical Considerations
The IVS Introducer Set Model 1003 typically comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard embolization coils and is designed for ease of insertion and stability during procedures. Clinicians should be familiar with vascular access techniques to optimize its use.
Frequently Asked Questions
What is the IVS Introducer Set Model 1003 used for?
It is used for vascular access in embolization procedures, allowing for the introduction of embolization coils into blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of embolization coils into the vascular system for embolization 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.