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delivery sheath model adelante breezeway
Oscor
Summary: The Adelante Breezeway is a delivery sheath used primarily in interventional cardiology and radiology for the delivery of embolization coils. It is utilized by specialists in catheter-based procedures.
FDA Clearance Information
Pathway
510K
Number
K101497 ↗
Decision Date
October 20, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Adelante Breezeway, manufactured by Oscor, was cleared via the FDA 510k pathway on October 20, 2010. It is classified as a Class 2 medical device under product code DYB.
What It Is
The Adelante Breezeway is a delivery sheath designed to facilitate the insertion and guidance of embolization coils into the vascular system. It provides a stable and flexible conduit for catheters and other devices, ensuring precise delivery to target sites. Its design minimizes trauma to the vessel wall and enhances procedural efficiency.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures requiring the deployment of embolization coils, such as in the treatment of aneurysms or arteriovenous malformations. It is suitable for use in hospital settings, particularly in catheterization labs, and is typically employed by interventional radiologists and cardiologists.
Indications for Use
The FDA-cleared indications for the Adelante Breezeway include its use in procedures that require the delivery of embolization coils. It is intended for patients needing vascular interventions to manage conditions like aneurysms.
Practical Considerations
The Adelante Breezeway is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and embolization devices, and clinicians should be familiar with the specific technique for sheath insertion to optimize outcomes.
Frequently Asked Questions
What is the Adelante Breezeway used for?
The Adelante Breezeway is used for delivering embolization coils during vascular interventions.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in catheter-based procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the delivery of embolization coils, such as treating aneurysms.
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.