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Terumo Medical
Summary: The Glidesheath Slender is a radial access sheath used in interventional cardiology and radiology. It is designed for vascular access during procedures like catheterizations. Typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K122980 ↗
Decision Date
December 11, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Glidesheath Slender by Terumo Medical was cleared through the FDA 510(k) pathway on December 11, 2012. It is a Class 2 device under product code DYB.
What It Is
The Glidesheath Slender is a specialized vascular access sheath designed to facilitate minimally invasive procedures via the radial artery. Its slender design aims to reduce the size of the access site, potentially minimizing complications such as bleeding and improving patient comfort. The sheath is used to introduce catheters and other devices into the vascular system during diagnostic and interventional procedures.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Glidesheath Slender is employed during procedures such as coronary angiography, angioplasty, and embolization. It is particularly beneficial in patients where radial access is preferred, such as those with peripheral vascular disease or at high risk for bleeding. The device is used in hospital settings, primarily by interventional cardiologists and radiologists.
Indications for Use
The Glidesheath Slender is indicated for use in vascular access during procedures requiring catheterization. It is suitable for patients undergoing diagnostic or interventional procedures where radial artery access is preferred.
Practical Considerations
The Glidesheath Slender is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and guidewires. Clinicians should be trained in radial access techniques to optimize outcomes and minimize complications.
Frequently Asked Questions
What is Glidesheath Slender used for?
The Glidesheath Slender is used for vascular access during interventional procedures like coronary angiography and angioplasty.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use the Glidesheath Slender.
What are the FDA-cleared indications?
The device is indicated for vascular access in procedures requiring catheterization, particularly through the radial artery.
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.