📋 FDA Reference
Delivery Sheath Model Adelante Breezeway
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in vascular procedures that require the introduction and delivery of embolization coils.
- Use as a delivery sheath to facilitate embolization of blood vessels.
- Use by trained clinicians for percutaneous vascular interventions.
Clinical Applications
- Delivery of embolization coils during treatment of selected aneurysms.
- Delivery of embolization coils for selected arteriovenous malformations.
- Vascular embolization procedures performed in an interventional radiology or cardiac catheterization laboratory.
Practical Considerations
- The appropriate sheath size and length depend on the access site, target vessel, anatomy and embolization system being used.
- The device should be used by clinicians trained in percutaneous vascular access, catheter manipulation and embolization techniques.
- Compatibility with the intended catheter and embolization coil system should be confirmed before the procedure.
- Potential complications are related to vascular access and catheterization and may include bleeding, hematoma, vessel injury, infection, thrombosis or embolic events.
- The available FDA record does not establish MRI safety; MRI use should follow the current manufacturer labeling and device-specific MR conditions.
Procedures that use this device
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.