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cordis avanti trans-radial catheter sheath introducer kit
Cordis
Summary: The Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit is a medical device used for vascular access in interventional procedures. It is primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway 510K
Number K962746 ↗
Decision Date October 11, 1996
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit was cleared by the FDA via the 510(k) pathway on October 11, 1996. It is manufactured by Cordis and classified as a Class 2 device under product code DYB.
What It Is
The Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit is designed to facilitate the introduction of catheters into the vascular system, specifically through the radial artery. It includes a sheath and dilator that help in minimizing trauma to the vessel during catheterization. This device is crucial in procedures requiring vascular access, providing a stable and secure entry point for various interventional tools.
Clinical Applications
This device is commonly used in cardiac catheterization procedures, such as angiography and percutaneous coronary interventions. It is favored in settings like cardiac catheterization labs and interventional radiology suites. The trans-radial approach is often preferred for its reduced risk of bleeding and quicker patient recovery, making it suitable for a wide range of patients, including those with coronary artery disease.
Indications for Use
The FDA-cleared indications for this device include facilitating vascular access for diagnostic and interventional procedures. It is particularly indicated for patients requiring catheterization via the radial artery, often in the context of cardiac or peripheral vascular interventions.
Practical Considerations
The Cordis Avanti Kit is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires. Clinicians should be trained in the trans-radial technique to optimize outcomes and minimize complications.
Frequently Asked Questions
What is the Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit used for?
It is used for gaining vascular access in interventional procedures, particularly through the radial artery.
What specialties typically use this device?
Cardiologists and interventional radiologists commonly use this device in procedures such as angiography and percutaneous coronary interventions.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access for diagnostic and interventional procedures, especially via the radial artery.
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.