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Fortress Introducer Sheath System
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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for the introduction and delivery of embolization coils.
- Access and device delivery during procedures that require placement of embolization coils within the vasculature.
Clinical Applications
- Providing vascular access for embolization-coil delivery.
- Supporting catheter-based treatment of selected aneurysms requiring coil embolization.
- Supporting catheter-based treatment of selected arteriovenous malformations requiring coil embolization.
Practical Considerations
- The system is available in different sheath and dilator sizes; the selected size should match the access vessel, delivery catheter and planned procedure.
- It is used with compatible guidewires, catheters and embolization coils according to the device labeling and institutional protocol.
- Insertion and removal require sterile technique and knowledge of vascular access, guidewire and catheter handling.
- Potential access-related complications include bleeding, hematoma, vessel injury, thrombosis, infection and, rarely, embolic complications.
- MRI safety should be confirmed from the current manufacturer labeling for the specific sheath system and any retained or associated components; do not assume MRI compatibility from the product category alone.
Procedures that use this device
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.