📋 FDA Reference
Ameco Sheath Introducer
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitates the introduction of catheters into blood vessels during procedures requiring vascular access.
Clinical Applications
- Obtaining vascular access for catheter-based procedures
- Providing a pathway for angiography and vascular imaging
- Supporting catheter delivery during embolization procedures
- Allowing catheter-based interventions in interventional radiology and cardiology
Practical Considerations
- The sheath size should match the selected catheter system, vessel size and planned procedure.
- Access is commonly obtained through the femoral, radial, brachial or jugular vessels, depending on the procedure and patient anatomy.
- The device is inserted using sterile technique and imaging guidance when appropriate; careful handling helps reduce bleeding, dissection and vessel trauma.
- MRI safety information is not established by the provided FDA record. The specific product labeling should be reviewed before MRI, particularly if any metallic components are present.
- Contraindications and precautions depend on the patient, access vessel, bleeding risk, local infection and the planned catheter procedure; clinicians should follow the manufacturer's instructions for use.
Procedures that use this device
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.