đź“‹ FDA Reference
convoy advanced delivery sheath
Boston Scientific
Summary: The Convoy Advanced Delivery Sheath is a medical device used primarily for the delivery of embolization coils in interventional radiology. It is utilized by specialists in vascular and interventional procedures to facilitate the placement of therapeutic devices.
FDA Clearance Information
Pathway
510K
Number
K072719 ↗
Decision Date
March 7, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Convoy Advanced Delivery Sheath was cleared through the FDA 510(k) pathway on March 7, 2008. Manufactured by Boston Scientific, it is classified as a Class 2 medical 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. It provides a conduit for the precise placement of these coils within the vascular system. The sheath is engineered to navigate the vasculature with flexibility and support, ensuring accurate delivery to the target site.
Clinical Applications
This device is commonly used in interventional radiology for procedures involving embolization, such as treating aneurysms or arteriovenous malformations. It is typically employed in hospital settings by interventional radiologists or vascular surgeons. The sheath is suitable for adult patients requiring vascular interventions.
Indications for Use
The Convoy Advanced Delivery Sheath is indicated for use in procedures that require the delivery of embolization coils. It is particularly useful in conditions where vascular occlusion is needed to prevent blood flow to specific areas, such as in the treatment of aneurysms.
Practical Considerations
The Convoy sheath is available in various sizes to accommodate different vascular anatomies and coil sizes. It is compatible with a range of embolization coils and requires careful handling to maintain sterility and functionality during procedures.
Frequently Asked Questions
What is the Convoy Advanced Delivery Sheath used for?
It is used for the delivery of embolization coils in vascular procedures, particularly in interventional radiology.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use 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.