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retroflex 3 introducer sheath set models 9120s23 and 9120s26
Edwards Lifesciences
Summary: The Retroflex 3 Introducer Sheath Set is a medical device used in vascular procedures to facilitate the introduction of catheters and other instruments. It is typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K093877 ↗
Decision Date
July 1, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Retroflex 3 Introducer Sheath Set, manufactured by Edwards Lifesciences, was cleared via the FDA 510(k) pathway on July 1, 2010. It is a Class 2 device under product code DYB.
What It Is
The Retroflex 3 Introducer Sheath Set is designed to provide a conduit for the introduction of catheters and other devices into the vascular system. It features a flexible sheath that can be navigated through the vasculature, minimizing trauma to the vessel walls. This device is particularly useful in procedures requiring precise placement of embolization coils or other interventional devices.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Retroflex 3 Introducer Sheath Set is employed in procedures such as embolization, where precise delivery of coils or other occlusive devices is necessary. It is suitable for use in hospital settings, particularly in catheterization labs, and is often used in patients requiring vascular interventions.
Indications for Use
The FDA indications for this device include its use in procedures involving the introduction of embolization coils. It is intended for patients who require vascular access for interventional procedures, particularly those involving the occlusion of blood vessels.
Practical Considerations
The Retroflex 3 Introducer Sheath Set is available in different sizes, such as models 9120s23 and 9120s26, to accommodate various patient anatomies and procedural requirements. It is important to select the appropriate size for the patient's vasculature to ensure optimal performance and safety.
Frequently Asked Questions
What is the Retroflex 3 Introducer Sheath Set used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system, particularly in procedures involving embolization coils.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the introduction of embolization coils, particularly for vascular access and occlusion.
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.