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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 vascular access. It is designed to facilitate the introduction of catheters and other devices into the vascular system, typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K153197 ↗
Decision Date
January 11, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Fortress Introducer Sheath System was cleared through the FDA 510(k) pathway on January 11, 2016. It is manufactured by Contract Medical International and classified as a Class II device under product code DYB.
What It Is
The Fortress Introducer Sheath System is a medical device designed to provide a conduit for the insertion of catheters and other interventional devices into the vascular system. It consists of a sheath and a dilator that allows for smooth and controlled access to blood vessels. This system is crucial in procedures requiring vascular access, ensuring minimal trauma to the vessel and facilitating the safe introduction of therapeutic devices.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures, such as angiography, embolization, and the placement of stents or coils. It is particularly useful in settings where precise vascular access is required, such as in the treatment of vascular malformations or during endovascular interventions. The device is suitable for use in adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The FDA-cleared indications for the Fortress Introducer Sheath System include its use in procedures requiring vascular access for the introduction of diagnostic or therapeutic devices. It is intended for patients undergoing interventions that necessitate the insertion of catheters or other devices into the vascular system.
Practical Considerations
The Fortress Introducer Sheath System is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and interventional devices. Clinicians should be familiar with the technique of sheath insertion to minimize the risk of vascular injury and ensure optimal device performance.
Frequently Asked Questions
What is the Fortress Introducer Sheath System used for?
It is used to facilitate the introduction of catheters and other interventional devices into the vascular system during procedures like angiography and embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for use in procedures that require vascular access for the insertion of diagnostic or therapeutic devices.
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.