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cordis cath sheath introduc mid-length sheath syst
Cordis
Summary: The Cordis Cath Sheath Introducer Mid-Length Sheath System is a medical device used to facilitate the introduction of catheters and other devices into the vascular system. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K861082 ↗
Decision Date
May 5, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Cath Sheath Introducer Mid-Length Sheath System was cleared through the FDA 510(k) pathway on May 5, 1986. Manufactured by Cordis, this device is classified as Class 2 under product code DYB.
What It Is
The Cordis Cath Sheath Introducer Mid-Length Sheath System is a vascular access device designed to aid in the insertion of catheters into the bloodstream. It consists of a sheath and dilator that provide a stable and secure entry point into the vascular system, minimizing trauma to the vessel. This system is essential for procedures requiring catheterization, such as angiography or the deployment of embolization coils.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings. It is crucial for procedures like angioplasty, stent placement, and embolization, where precise vascular access is required. The sheath system is often used in hospitals and specialized clinics, catering to adult and pediatric patients requiring vascular interventions.
Indications for Use
The Cordis Cath Sheath Introducer is indicated for patients needing vascular access for diagnostic or therapeutic interventions. It is suitable for conditions requiring catheter-based treatments, such as coronary artery disease or vascular malformations.
Practical Considerations
The sheath system is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires, and clinicians should ensure proper sizing and technique to minimize complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the Cordis Cath Sheath Introducer Mid-Length Sheath System used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system for diagnostic and therapeutic procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for providing vascular access for catheter-based interventions in patients requiring diagnostic or therapeutic procedures.
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.