đź“‹ FDA Reference
epic introducer sheath
North American Instrument
Summary: The Epic Introducer Sheath is a medical device used primarily in interventional radiology and cardiology to facilitate the insertion of catheters and other devices into blood vessels. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K960310 ↗
Decision Date
February 7, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Epic Introducer Sheath was cleared through the FDA 510(k) pathway on February 7, 1996. It is manufactured by North American Instrument and is classified as a Class 2 device under product code DYB.
What It Is
The Epic Introducer Sheath is a tubular device designed to provide a stable and secure pathway for the insertion of catheters and other interventional devices into the vascular system. It typically consists of a sheath, dilator, and hemostatic valve to prevent blood loss during procedures. The device is crucial in minimizing trauma to the vessel and ensuring smooth device exchanges.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as angiography, embolization, and catheter-based interventions. It is particularly useful in interventional radiology and cardiology settings, where precision and stability are paramount. The sheath is used in both elective and emergency procedures, catering to a wide range of patient populations, from those requiring diagnostic imaging to those undergoing therapeutic interventions.
Indications for Use
The Epic Introducer Sheath is indicated for use in patients requiring vascular access for diagnostic or therapeutic procedures. It is suitable for conditions that necessitate the insertion of catheters or other devices into the vascular system, such as during embolization or angiographic studies.
Practical Considerations
The Epic Introducer Sheath is available in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with a range of catheters and guidewires. Clinicians should be familiar with the insertion technique to minimize complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the Epic Introducer Sheath used for?
It is used to facilitate the insertion 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 use in patients requiring vascular access for diagnostic or therapeutic procedures, such as embolization or 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.