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isleeve introducer set
Boston Scientific
Summary: The isleeve Introducer Set by Boston Scientific is a medical device used for vascular access during embolization procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K190184 ↗
Decision Date
March 7, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The isleeve Introducer Set was cleared via the FDA 510(k) pathway on March 7, 2019. 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 insertion of catheters and other instruments into blood vessels. It consists of a sheath and dilator that help in creating and maintaining vascular access. This device is particularly useful in procedures requiring precise and stable access to the vascular system, such as embolization.
Clinical Applications
The isleeve Introducer Set is commonly used in interventional radiology and cardiology for procedures like embolization, where stable vascular access is crucial. It is used in hospital settings, particularly in catheterization labs, to assist in the delivery of embolization coils and other devices. The device is suitable for adult patients requiring vascular interventions.
Indications for Use
The FDA indications for the isleeve Introducer Set involve its use in procedures where vascular access is needed, such as the placement of embolization coils. It is intended for patients requiring interventions that involve accessing the vascular system.
Practical Considerations
The isleeve Introducer Set is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and embolization devices. Clinicians should be familiar with the technique of sheath insertion and ensure proper sizing to minimize complications.
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 valve system in aortic valve replacement. Although the abstract is not available, the study likely investigates the safety and efficacy of the LOTUS EDGE Valve System. Limitations may include the lack of detailed results and specific patient outcomes.
Frequently Asked Questions
What is the isleeve Introducer Set used for?
The isleeve Introducer Set is used for gaining vascular access during procedures like embolization, allowing for the insertion of catheters and other devices.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the isleeve Introducer Set in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated 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.