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fortress introducer sheath system
Contract Medical International
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 clinicians to facilitate vascular access and device delivery.
FDA Clearance Information
Pathway
510K
Number
K203179 ↗
Decision Date
November 20, 2020
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Fortress Introducer Sheath System was cleared through the FDA 510(k) pathway on November 20, 2020. It is manufactured by Contract Medical International and classified as a Class 2 device under product code DYB.
What It Is
The Fortress Introducer Sheath System is a vascular access device designed to facilitate the introduction of other medical devices, such as embolization coils, into the vascular system. It consists of a sheath and dilator that help in navigating through blood vessels with minimal trauma. This device is essential for procedures requiring precise device placement within the vasculature.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Fortress Introducer Sheath System is employed in procedures like embolization, where precise delivery of coils is necessary to occlude blood vessels. It is used in hospital settings, particularly in catheterization labs, and is suitable for adult and pediatric patients requiring vascular interventions.
Indications for Use
The device is indicated for use in patients requiring vascular access for the delivery of embolization coils. This includes conditions such as aneurysms or arteriovenous malformations where blood flow needs to be controlled or redirected.
Practical Considerations
The sheath system typically comes in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of embolization coils and other interventional devices. Clinicians should be familiar with vascular anatomy and access techniques to ensure successful device deployment.
Frequently Asked Questions
What is the Fortress Introducer Sheath System used for?
It is used for vascular access to facilitate the introduction of embolization coils and other devices into the bloodstream.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for vascular access in procedures requiring the delivery of embolization coils, such as treating aneurysms or arteriovenous malformations.
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.