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entree sheath introducer system
Cordis
Summary: The Entree Sheath Introducer System by Cordis is a medical device used primarily in vascular procedures to facilitate the introduction of catheters and other devices. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K904475 ↗
Decision Date
April 1, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Entree Sheath Introducer System was cleared through the FDA 510(k) pathway on April 1, 1991. It is manufactured by Cordis and classified as a Class 2 device under product code DYB.
What It Is
The Entree Sheath Introducer System is a medical device designed to provide a conduit for the insertion of catheters and other instruments into the vascular system. It typically consists of a sheath and a dilator, which help in accessing blood vessels with minimal trauma. The device is crucial in procedures requiring vascular access, ensuring smooth and safe introduction of therapeutic or diagnostic tools.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures such as angiography, angioplasty, and the deployment of embolization coils. It is particularly useful in settings where precise vascular access is required, such as in the treatment of vascular occlusions or aneurysms. The system is suitable for a wide range of patient populations, including those undergoing elective or emergency vascular interventions.
Indications for Use
The FDA indications for the Entree Sheath Introducer System involve its use in facilitating the introduction of catheters and other devices into the vascular system. It is indicated for patients requiring vascular access for diagnostic or therapeutic procedures.
Practical Considerations
The Entree Sheath Introducer System is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and guidewires, and clinicians should select the appropriate size based on the specific procedure and patient anatomy. Proper technique in insertion and removal is essential to minimize vascular trauma.
Frequently Asked Questions
What is the Entree Sheath Introducer System used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system for 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.