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cordis avanti catheter sheath introducer
Cordis
Summary: The Cordis Avanti Catheter Sheath Introducer is a medical device used primarily in interventional procedures to facilitate the introduction of catheters into blood vessels. It is commonly used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K945616 ↗
Decision Date
March 29, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Avanti Catheter Sheath Introducer was cleared via the FDA 510k pathway on March 29, 1995. Manufactured by Cordis, it is classified as a Class 2 device under product code DYB.
What It Is
The Cordis Avanti Catheter Sheath Introducer is a medical device designed to provide a conduit for the insertion of catheters into the vascular system. It consists of a sheath and dilator, allowing for smooth entry and minimizing trauma to the vessel. This device is essential in procedures requiring vascular access, such as angiography and interventional cardiology.
Clinical Applications
This device is commonly used in interventional cardiology and radiology to facilitate catheter-based procedures. It is particularly useful in settings where vascular access is required, such as during coronary angiography or peripheral interventions. The introducer is suitable for adult patients undergoing these procedures, and its use is prevalent in both hospital and outpatient settings.
Indications for Use
The FDA indications for the Cordis Avanti Catheter Sheath Introducer include its use in procedures requiring vascular access for catheter insertion. It is intended for patients undergoing diagnostic or interventional procedures involving the arterial or venous systems.
Practical Considerations
The Cordis Avanti Catheter Sheath Introducer is available in various sizes to accommodate different catheter diameters. It is compatible with a range of catheter types and is designed to minimize vessel trauma during insertion. Clinicians should be familiar with the technique of sheath insertion to optimize outcomes.
Related Literature
The linked study explored the use of the Glidesheath Slender, a similar device, to reduce radial artery occlusion following 7 French transradial coronary intervention. Although specific details are not provided, the study likely focused on the efficacy and safety of using a slender sheath to minimize complications. Limitations include the lack of an abstract and detailed findings, which restricts comprehensive analysis.
Frequently Asked Questions
What is the Cordis Avanti Catheter Sheath Introducer used for?
It is used to facilitate the introduction of catheters into blood vessels during interventional procedures.
What specialties typically use this device?
Cardiology and interventional radiology are the primary specialties that use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access for catheter insertion, such as angiography and interventional cardiology.
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.