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edwards esheath introducer set
Edwards Lifesciences
Summary: The Edwards eSheath Introducer Set is a medical device used to facilitate the insertion of catheters and other devices into the vascular system. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K200258 ↗
Decision Date
March 9, 2020
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Edwards eSheath Introducer Set was cleared via the FDA 510(k) pathway on March 9, 2020. Manufactured by Edwards Lifesciences, it is classified as a Class 2 device under product code DYB.
What It Is
The Edwards eSheath Introducer Set is a device designed to provide a conduit for the introduction of catheters and other interventional devices into the vascular system. It features a sheath that can expand and contract to accommodate various device sizes, minimizing vascular trauma during procedures. This introducer set is particularly useful in procedures requiring precise vascular access and device stability.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Edwards eSheath Introducer Set is employed in procedures such as transcatheter aortic valve replacement (TAVR) and other catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs, and is used for patients requiring minimally invasive vascular access.
Indications for Use
The FDA indications for the Edwards eSheath Introducer Set include its use in facilitating the insertion of catheters and other devices into the vascular system. It is intended for patients undergoing procedures that require vascular access, such as those with cardiovascular conditions.
Practical Considerations
The Edwards eSheath Introducer Set comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and devices, and clinicians should be familiar with the specific technique for insertion to ensure optimal outcomes.
Related Literature
The J-Valve Transfemoral Pivotal Study investigated the use of the Edwards eSheath Introducer Set in the context of transfemoral valve implantation. Although the study's abstract is not available, it likely focused on the safety and efficacy of the device in facilitating valve delivery. Limitations include the lack of detailed study data and outcomes.
Frequently Asked Questions
What is the Edwards eSheath Introducer Set used for?
It is used to facilitate the insertion of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the insertion of catheters and other devices into the vascular system for patients undergoing procedures requiring vascular access.
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.