📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Provides vascular access for diagnostic procedures requiring catheter placement.
- Provides vascular access for therapeutic procedures requiring catheter or device placement.
- Facilitates the introduction and exchange of catheters and other interventional devices within the vascular system.
Clinical Applications
- Access for angiographic imaging procedures.
- Access for catheter-based embolization procedures.
- Access for diagnostic vascular catheterization.
- Access for therapeutic interventional procedures requiring catheter or device exchanges.
Practical Considerations
- Available sizes should be selected according to the access vessel, catheter or device diameter, and planned procedure.
- The sheath is typically used with a dilator, guidewire, and hemostatic valve; clinicians should confirm compatibility before use.
- Insertion requires sterile technique and image-guided or standard vascular access techniques appropriate to the procedure.
- Potential complications include bleeding, hematoma, vessel injury, thrombosis, infection, and loss of access.
- MRI safety depends on the specific materials and labeling of the device; the product-specific instructions for use should be checked before MRI. The sheath is generally a temporary procedural device and is removed after the intervention unless the labeling specifies otherwise.
Procedures that use this device
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.