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isleeve introducer set
Boston Scientific
Summary: The isleeve introducer set by Boston Scientific is a medical device used primarily in embolization procedures. It is typically utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K202584 ↗
Decision Date
October 6, 2020
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The isleeve introducer set was cleared through the FDA 510(k) pathway on October 6, 2020. It is manufactured by Boston Scientific and classified as a Class 2 device under product code DYB.
What It Is
The isleeve introducer set is a medical device designed to facilitate the introduction of catheters and other instruments into the vascular system. It is commonly used in minimally invasive procedures to provide a stable and secure access point. The device is engineered to minimize trauma to the vessel and ensure smooth passage of instruments.
Clinical Applications
This device is frequently used in interventional radiology and cardiology for procedures such as embolization, where precise delivery of coils or other embolic agents is required. It is suitable for use in hospital settings, particularly in catheterization labs. The device is often used in adult patients who require vascular access for therapeutic or diagnostic interventions.
Indications for Use
The isleeve introducer set is indicated for use in procedures requiring vascular access, particularly in embolization cases. It is designed to assist in the delivery of embolization coils and other devices to targeted areas within the vascular system.
Practical Considerations
The isleeve introducer set is available in various sizes to accommodate different vessel diameters. It is compatible with a range of catheters and embolization devices. Clinicians should be familiar with the specific technique for inserting and securing the introducer to ensure optimal performance.
Related Literature
The linked study titled 'REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System' explores the use of a repositionable valve system in aortic valve replacement. While the abstract is not available, the study likely investigates the efficacy and safety of the valve system. Limitations may include the lack of long-term outcome data and specific patient population details.
Frequently Asked Questions
What is isleeve introducer set used for?
The isleeve introducer set is used for vascular access in procedures like embolization, facilitating the introduction of catheters and other devices.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use the isleeve introducer set in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular access procedures, particularly in embolization, to assist in the delivery of embolization coils and other devices.
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.