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cordis nihon catheter sheath introducer
Cordis
Summary: The Cordis Nihon Catheter Sheath Introducer is a medical device used to facilitate the insertion of catheters into blood vessels. It is commonly used by interventional radiologists and cardiologists during procedures such as embolization.
FDA Clearance Information
Pathway
510K
Number
K931102 ↗
Decision Date
May 27, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Nihon Catheter Sheath Introducer was cleared through the FDA 510(k) pathway on May 27, 1993. It is manufactured by Cordis and classified as a Class 2 device under product code DYB.
What It Is
The Cordis Nihon Catheter Sheath Introducer is a medical device designed to aid in the insertion of catheters into blood vessels. It consists of a sheath and a dilator that help in creating a pathway for the catheter, minimizing trauma to the vessel. This device is crucial in procedures requiring vascular access, ensuring that catheters can be introduced smoothly and safely.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, where precise catheter placement is necessary. It is used in hospital settings, particularly in catheterization labs, and is suitable for adult patients requiring vascular interventions. The introducer is essential in procedures that involve the placement of embolization coils to treat aneurysms or other vascular abnormalities.
Indications for Use
The FDA indications for this device include facilitating the insertion of catheters into blood vessels. It is used in patients requiring vascular access for procedures like embolization, where precise catheter placement is critical.
Practical Considerations
The Cordis Nihon Catheter Sheath Introducer comes in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with standard catheters used in vascular procedures. Clinicians should be familiar with the insertion technique to minimize complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the Cordis Nihon Catheter Sheath Introducer used for?
It is used to facilitate the insertion of catheters into blood vessels during procedures like embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of catheters into blood vessels, 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.