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Cordis Webster
Summary: The Cordis Webster Preface Braided Guiding Sheath is a medical device used primarily in interventional cardiology and radiology for guiding catheters during procedures. It is utilized by specialists in hospitals and clinical settings.
FDA Clearance Information
Pathway
510K
Number
K982740 ↗
Decision Date
August 28, 1998
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Webster Preface Braided Guiding Sheath was cleared through the FDA 510(k) pathway on August 28, 1998. Manufactured by Cordis Webster, it is classified as a Class II medical device.
What It Is
The Cordis Webster Preface Braided Guiding Sheath is a flexible tube designed to facilitate the introduction and guidance of catheters into the vascular system. It features a braided construction that provides enhanced torque control and kink resistance, which is crucial during complex interventional procedures. This device is commonly used in conjunction with catheters for diagnostic and therapeutic interventions.
Clinical Applications
This guiding sheath is commonly used in interventional cardiology and radiology to aid in the placement of catheters during procedures such as angiography, embolization, and other vascular interventions. It is particularly useful in settings where precise catheter manipulation is required, such as in the treatment of coronary artery disease or peripheral vascular disease. The device is suitable for use in adult patients undergoing these types of procedures.
Indications for Use
The FDA indications for this device include its use in guiding catheters for embolization procedures, which involve blocking blood vessels to prevent blood flow to a particular area, often to treat aneurysms or tumors. It is designed for use in patients requiring such interventions.
Practical Considerations
The Cordis Webster Preface Braided Guiding Sheath is available in various sizes to accommodate different catheter types and patient anatomies. It is compatible with a range of catheter systems, and clinicians should ensure proper sizing and compatibility before use. The braided design offers improved control, which is beneficial in complex vascular procedures.
Frequently Asked Questions
What is the Cordis Webster Preface Braided Guiding Sheath used for?
It is used to guide catheters during interventional procedures such as angiography and embolization.
What specialties typically use this device?
Interventional cardiologists and radiologists primarily use this device in hospital and clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in guiding catheters during embolization procedures to treat conditions like aneurysms or tumors.
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.