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cordis brite tip sheath introducer
Cordis
Summary: The Cordis Brite Tip Sheath Introducer is a medical device used to facilitate the introduction of catheters and other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K954595 ↗
Decision Date
December 28, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Brite Tip Sheath Introducer was cleared through the FDA 510(k) pathway on December 28, 1995. It is manufactured by Cordis and classified as a Class 2 device.
What It Is
The Cordis Brite Tip Sheath Introducer is a vascular access device designed to provide a conduit for the insertion of catheters and other interventional tools into the vascular system. It features a tapered tip to facilitate smooth entry and minimize trauma to the vessel. The device is typically used in procedures requiring vascular access, such as angiography or the deployment of embolization coils.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings. It is essential for procedures that require precise vascular access, such as coronary angiography, peripheral angioplasty, and the placement of embolization coils. The sheath introducer is suitable for adult patients requiring these interventions, and it is often used in hospital catheterization labs.
Indications for Use
The FDA indications for the Cordis Brite Tip Sheath Introducer include facilitating the introduction of catheters into the vascular system. It is intended for patients undergoing procedures that require vascular access, such as those with vascular diseases or requiring embolization.
Practical Considerations
The Cordis Brite Tip Sheath Introducer comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and guidewires. Clinicians should be familiar with the technique of sheath insertion to minimize complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the Cordis Brite Tip Sheath Introducer 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 cardiologists and radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters into the vascular system, particularly in procedures requiring vascular access.
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.