đź“‹ FDA Reference
fortress introducer sheath system model 358813 358814 358815
Contract Medical Intl.
Summary: The Fortress Introducer Sheath System is a medical device used primarily in interventional radiology and cardiology for the introduction of embolization coils. It is utilized by specialists to facilitate vascular access during minimally invasive procedures.
FDA Clearance Information
Pathway
510K
Number
K100799 ↗
Decision Date
February 25, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Fortress Introducer Sheath System, manufactured by Contract Medical Intl., received FDA clearance through the 510(k) pathway on February 25, 2011. It is classified as a Class 2 medical device under product code DYB.
What It Is
The Fortress Introducer Sheath System is designed to provide a conduit for the insertion of embolization coils into the vascular system. It consists of a flexible tube that allows for smooth navigation through blood vessels, minimizing trauma to the vessel walls. This device is essential in procedures requiring precise delivery of therapeutic agents or devices within the vascular system.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures such as embolization, where it aids in the delivery of coils to occlude blood vessels. It is particularly useful in treating conditions like aneurysms or arteriovenous malformations. The sheath system is employed in hospitals and specialized clinics, primarily by interventional radiologists and cardiologists.
Indications for Use
The FDA has cleared the Fortress Introducer Sheath System for use in delivering embolization coils, which are used to block blood flow in specific vessels. This is typically indicated for patients with vascular abnormalities such as aneurysms or other conditions requiring targeted vessel occlusion.
Practical Considerations
The sheath system is available in various sizes to accommodate different vessel diameters, ensuring compatibility with a range of embolization coils. Clinicians should be familiar with the specific technique for sheath insertion and coil deployment to optimize outcomes and minimize complications.
Frequently Asked Questions
What is the Fortress Introducer Sheath System used for?
It is used for introducing embolization coils into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in hospital and specialized clinic settings.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils to occlude blood vessels in patients with vascular abnormalities.
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.