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cordis webster braided guiding sheath exchange system
Cordis Webster
Summary: The Cordis Webster Braided Guiding Sheath Exchange System is a medical device used primarily in interventional cardiology and radiology for guiding catheters during embolization procedures. It is typically used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K970264 ↗
Decision Date
October 28, 1997
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Webster Braided Guiding Sheath Exchange System was cleared via the FDA 510(k) pathway on October 28, 1997. It is manufactured by Cordis Webster and classified as a Class 2 device under product code DYB.
What It Is
The Cordis Webster Braided Guiding Sheath Exchange System is designed to facilitate the exchange and placement of catheters within the vascular system. It features a braided design that provides enhanced flexibility and torque control, allowing for precise navigation through the vasculature. This device is particularly useful in procedures requiring the placement of embolization coils, where stability and control are critical.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly for procedures involving the placement of embolization coils to treat vascular abnormalities such as aneurysms or arteriovenous malformations. It is used in hospital catheterization labs and interventional suites, primarily by cardiologists and interventional radiologists. The patient population includes those requiring minimally invasive treatment for vascular conditions.
Indications for Use
The FDA indications for this device involve its use in guiding catheters during embolization procedures. It is intended for patients who require precise catheter placement for the delivery of embolization coils to treat vascular conditions.
Practical Considerations
The Cordis Webster Braided Guiding Sheath is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard catheterization equipment and requires familiarity with catheter exchange techniques. Clinicians should be aware of the device's torque control capabilities to optimize procedural outcomes.
Frequently Asked Questions
What is the Cordis Webster Braided Guiding Sheath used for?
It is used to guide catheters during embolization procedures, particularly for placing embolization coils.
What specialties typically use this device?
This device is commonly used by interventional cardiologists and radiologists.
What are the FDA-cleared indications?
The device is indicated for use in guiding catheters for embolization procedures to treat vascular conditions.
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.