đź“‹ FDA Reference
emcee infusion introducer sheath emcee infusion introducer set dilator emcee infusion introducer sheath set emcee inf
Schneider/Namic
Summary: The Emcee Infusion Introducer Sheath is a medical device used primarily in interventional radiology and cardiology for the introduction of catheters and other devices into the vascular system. It is used by healthcare professionals such as interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K983039 ↗
Decision Date
May 7, 1999
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Emcee Infusion Introducer Sheath, manufactured by Schneider/Namic, received FDA clearance through the 510(k) pathway on May 7, 1999. It is classified as a Class 2 device under product code DYB.
What It Is
The Emcee Infusion Introducer Sheath is a medical device designed to facilitate the introduction of catheters and other interventional tools into the vascular system. It consists of a sheath and a dilator, which help in creating a pathway into blood vessels, minimizing trauma during insertion. This device is essential in procedures requiring vascular access, providing a stable and secure entry point for various diagnostic and therapeutic interventions.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Emcee Infusion Introducer Sheath is employed in procedures such as embolization, angiography, and catheter-based interventions. It is particularly useful in settings like hospitals and specialized clinics where minimally invasive vascular procedures are performed. The device is suitable for adult patients requiring vascular access for diagnostic or therapeutic purposes.
Indications for Use
The FDA-cleared indications for the Emcee Infusion Introducer Sheath include its use in facilitating the introduction of catheters and other devices into the vascular system. It is indicated for patients undergoing procedures that require vascular access, such as embolization.
Practical Considerations
The Emcee Infusion Introducer Sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and interventional devices. Clinicians should ensure proper sizing and technique to minimize vascular trauma and optimize procedural outcomes.
Frequently Asked Questions
What is the Emcee Infusion Introducer Sheath 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 their procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system, particularly for procedures like embolization.
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.