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gore introducer sheath with silicone pinch valve
W.L. Gore & Associates
Summary: The Gore Introducer Sheath with Silicone Pinch Valve is a medical device used to facilitate the insertion of catheters and other devices into blood vessels. It is primarily used by interventional radiologists and vascular surgeons during procedures like embolization.
FDA Clearance Information
Pathway
510K
Number
K082356 ↗
Decision Date
August 28, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Gore Introducer Sheath with Silicone Pinch Valve was cleared through the FDA 510k pathway on August 28, 2008. Manufactured by W.L. Gore & Associates, it is classified as a Class 2 device under product code DYB.
What It Is
The Gore Introducer Sheath with Silicone Pinch Valve is a specialized medical device designed to provide vascular access for the insertion of catheters and other medical instruments. The silicone pinch valve minimizes blood leakage during procedures, enhancing procedural safety and efficiency. This device is particularly useful in complex interventions where multiple devices need to be introduced into the vascular system.
Clinical Applications
This introducer sheath is commonly used in interventional radiology and vascular surgery, particularly during procedures such as embolization and endovascular aneurysm repair. It is suitable for use in hospital settings, especially in catheterization labs where precision and control are critical. The device is often employed in adult patients requiring complex vascular interventions.
Indications for Use
The FDA indications for the Gore Introducer Sheath with Silicone Pinch Valve 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 embolization or aneurysm repair.
Practical Considerations
The Gore Introducer Sheath is available in various sizes to accommodate different procedural needs and patient anatomies. It is compatible with a range of catheters and guidewires, making it versatile for various interventions. Clinicians should be familiar with the insertion technique to ensure optimal performance and minimize complications.
Related Literature
The linked study compared leakage rates of various large bore sheaths used in fenestrated endovascular aneurysm repair (fEVAR). It assessed the performance of the Gore DrySeal Flex, Cook Performer Check-Flo, and Medtronic Sentrant in an in vitro setting. The study found that all sheaths experienced some degree of blood leakage when multiple smaller sheaths were inserted, highlighting the need for improved valve designs. However, the study's in vitro nature may limit its applicability to clinical practice.
Frequently Asked Questions
What is Gore Introducer Sheath with Silicone Pinch Valve used for?
It is used to facilitate the insertion of catheters and other medical devices into blood vessels during procedures like embolization and aneurysm repair.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings, particularly during complex vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating vascular access for the insertion of catheters and other devices during procedures such as embolization and aneurysm repair.
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.