đź“‹ FDA Reference
isleeve introducer set
Boston Scientific
Summary: The isleeve introducer set 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
K180785 ↗
Decision Date
June 22, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The isleeve introducer set was cleared through the FDA 510(k) pathway on June 22, 2018. It is manufactured by Boston Scientific and classified as a Class 2 device.
What It Is
The isleeve introducer set is a vascular access device designed to facilitate the insertion of catheters and other instruments into the vascular system. It typically consists of a sheath and dilator, allowing for smooth entry into blood vessels. This device is crucial in procedures requiring precise and stable vascular access, such as embolization.
Clinical Applications
The isleeve introducer set is commonly used in interventional radiology and cardiology for procedures like embolization, where precise vascular access is necessary. It is used in hospital settings, particularly in catheterization labs, and is suitable for adult patients requiring vascular interventions. The device aids in the delivery of embolization coils and other therapeutic agents.
Indications for Use
The isleeve introducer set is indicated for use in patients requiring vascular access for procedures such as embolization. It is designed to provide a stable and reliable entry point for catheters and other devices used in these interventions.
Practical Considerations
The isleeve introducer set comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard catheters and embolization devices. Clinicians should be familiar with the device's insertion technique to minimize vascular trauma.
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. Although specific findings are not available, the study likely investigates procedural outcomes and device efficacy. Limitations include the lack of an abstract and detailed results.
Frequently Asked Questions
What is the isleeve introducer set used for?
It is used for vascular access in procedures like embolization, allowing for the insertion of catheters and other devices.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients undergoing procedures such as embolization.
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.