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ameco sheath introducer
Ameco Medical Industries
Summary: The Ameco Sheath Introducer is a medical device used to facilitate the insertion of catheters into blood vessels. It is primarily used by interventional radiologists and cardiologists in procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K131144 ↗
Decision Date
August 15, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Ameco Sheath Introducer was cleared through the FDA 510k pathway on August 15, 2013. Manufactured by Ameco Medical Industries, it is classified as a Class 2 device under product code DYB.
What It Is
The Ameco Sheath Introducer is a medical device designed to aid in the insertion of catheters into blood vessels. It consists of a sheath that provides a stable pathway for catheters, minimizing trauma to the vessel during insertion. This device is crucial in procedures requiring vascular access, ensuring safe and efficient catheter placement.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Ameco Sheath Introducer is essential in procedures such as angiography, embolization, and other catheter-based interventions. It is used in hospital settings, particularly in catheterization labs, and is suitable for a wide range of patient populations requiring vascular access.
Indications for Use
The FDA-cleared indications for the Ameco Sheath Introducer include facilitating catheter insertion during procedures that require vascular access. It is used in patients undergoing interventions such as embolization or angiography.
Practical Considerations
The Ameco Sheath Introducer typically comes in various sizes to accommodate different vessel diameters and catheter sizes. It is compatible with a range of catheters and should be selected based on the specific procedure and patient anatomy. Proper technique is essential to minimize vessel trauma and ensure successful catheter placement.
Frequently Asked Questions
What is the Ameco Sheath Introducer used for?
It is used to facilitate the insertion of catheters into blood vessels during procedures requiring vascular access.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures involving vascular access.
What are the FDA-cleared indications?
The device is indicated for use in facilitating catheter insertion during vascular access procedures such as embolization and angiography.
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.