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delivery sheath model adelante breezeway
Oscor
Summary: The Adelante Breezeway is a delivery sheath used in interventional procedures, primarily for embolization-coils. It is utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K122958 ↗
Decision Date
December 13, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Adelante Breezeway by Oscor was cleared through the FDA 510(k) pathway on December 13, 2012. It is a Class 2 medical device under product code DYB.
What It Is
The Adelante Breezeway is a delivery sheath designed to facilitate the introduction of embolization coils into the vascular system. It provides a stable and flexible conduit for the delivery of these coils during interventional procedures. The sheath is engineered to minimize trauma to the vessel wall and ensure precise placement of the coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures involving embolization, such as treating aneurysms or arteriovenous malformations. It is typically used in hospital settings, particularly in catheterization labs or interventional suites, and is suitable for adult and pediatric patients requiring vascular interventions.
Indications for Use
The Adelante Breezeway is indicated for use in patients requiring embolization procedures, where embolization coils are deployed to occlude blood vessels. This is often necessary in conditions such as aneurysms or vascular malformations.
Practical Considerations
The Adelante Breezeway is available in various sizes to accommodate different vessel diameters. It is compatible with standard embolization coils and should be used by clinicians familiar with vascular access techniques. Proper sizing and technique are crucial to minimize complications.
Frequently Asked Questions
What is Adelante Breezeway used for?
It is used for delivering embolization coils into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to occlude blood vessels in conditions like aneurysms or vascular 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.