đź“‹ FDA Reference
percutaneous sheath introducer tray
Packaging Technologies
Summary: The percutaneous sheath introducer tray is a medical device used to facilitate vascular access during procedures. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K834074 ↗
Decision Date
March 19, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous sheath introducer tray by Packaging Technologies was cleared through the FDA 510(k) pathway on March 19, 1984. It is classified as a Class 2 device under the product code DYB.
What It Is
The percutaneous sheath introducer tray is a medical device designed to provide a stable and secure entry point into the vascular system. It typically includes a sheath, dilator, and guidewire, allowing clinicians to introduce catheters and other instruments into blood vessels. This device is essential in procedures requiring vascular access, such as angiography or the deployment of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures that require vascular access, such as angioplasty, stent placement, or embolization. It is used in hospitals and outpatient surgical centers, primarily for adult patients undergoing minimally invasive procedures. The device is crucial for ensuring safe and effective access to the vascular system.
Indications for Use
The percutaneous sheath introducer tray is indicated for use in procedures that require vascular access, such as the introduction of catheters or other instruments into the bloodstream. It is suitable for patients undergoing procedures like angiography or embolization.
Practical Considerations
The device typically comes in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with standard guidewires and catheters. Clinicians should be familiar with the technique of sheath insertion to minimize complications such as bleeding or vessel trauma.
Frequently Asked Questions
What is the percutaneous sheath introducer tray used for?
It is used to facilitate vascular access during procedures such as angiography or embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access, such as catheter insertion for angiography or 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.