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modification to convoy advanced delivery sheath
Boston Scientific
Summary: The Convoy Advanced Delivery Sheath is a medical device used primarily in interventional radiology for the delivery of embolization coils. It is utilized by specialists in vascular procedures to facilitate precise placement of therapeutic devices.
FDA Clearance Information
Pathway
510K
Number
K034061 ↗
Decision Date
January 30, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Convoy Advanced Delivery Sheath was cleared through the FDA 510(k) pathway on January 30, 2004. Manufactured by Boston Scientific, it is classified as a Class 2 device under product code DYB.
What It Is
The Convoy Advanced Delivery Sheath is a specialized catheter designed to aid in the delivery of embolization coils during endovascular procedures. It provides a stable and flexible conduit for the precise placement of coils into targeted vascular sites. The sheath's design allows for smooth navigation through the vascular system, minimizing trauma to vessel walls.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures involving embolization, such as treating aneurysms or arteriovenous malformations. It is particularly useful in settings requiring precise delivery of embolic materials, often in hospital catheterization labs or specialized outpatient centers. The sheath is suitable for adult patients requiring vascular embolization.
Indications for Use
The FDA-cleared indications for the Convoy Advanced Delivery Sheath involve its use in delivering embolization coils to treat vascular abnormalities. It is intended for patients with conditions that necessitate the occlusion of blood vessels to prevent hemorrhage or reduce blood flow to a specific area.
Practical Considerations
Clinicians should consider the sheath's compatibility with various embolization coils and ensure appropriate sizing for the target vessel. The device's flexibility and stability are key features that facilitate its use in complex vascular anatomies. Proper technique in navigation and placement is essential for optimal outcomes.
Frequently Asked Questions
What is the Convoy Advanced Delivery Sheath used for?
It is used for the delivery of embolization coils during vascular procedures to treat conditions like aneurysms.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The sheath is indicated for delivering embolization coils to occlude blood vessels in treating 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.