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edwards esheath optima introducer set
Edwards Lifesciences
Summary: The Edwards eSheath Optima Introducer Set is a medical device used for vascular access during embolization procedures. It is typically utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K252364 ↗
Decision Date
August 29, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Edwards eSheath Optima Introducer Set was cleared via the FDA 510k pathway on August 29, 2025. Manufactured by Edwards Lifesciences, it is a Class 2 device under product code DYB.
What It Is
The Edwards eSheath Optima Introducer Set is a vascular access device designed to facilitate the introduction of other medical devices into the vascular system. It features a sheath and dilator system that allows for smooth and controlled access, minimizing trauma to the vessel. This device is particularly useful in procedures requiring precise device placement within the vasculature.
Clinical Applications
This introducer set is commonly used in interventional cardiology and radiology for procedures such as embolization, where precise vascular access is critical. It is suitable for use in hospital settings, particularly in catheterization labs and interventional suites. The device is designed for adult patients requiring vascular interventions.
Indications for Use
The FDA indications for this device include its use in facilitating the placement of embolization coils within the vasculature. It is intended for patients requiring embolization to treat conditions such as aneurysms or vascular malformations.
Practical Considerations
The Edwards eSheath Optima Introducer Set is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of embolization devices, and clinicians should ensure proper sizing and technique to optimize outcomes.
Frequently Asked Questions
What is the Edwards eSheath Optima Introducer Set used for?
It is used for vascular access during embolization procedures, facilitating the introduction of embolization coils.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating the placement of embolization coils in the vasculature for treating conditions like aneurysms.
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.