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breezeway ii
Oscor
Summary: The Breezeway II by Oscor is a medical device used in embolization procedures. It is primarily utilized by interventional radiologists and vascular surgeons to treat vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K210627 ↗
Decision Date
June 3, 2021
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Breezeway II received FDA clearance through the 510(k) pathway on June 3, 2021. It is manufactured by Oscor and classified as a Class 2 medical device under product code DYB.
What It Is
The Breezeway II is an embolization coil system designed to occlude blood vessels. It works by being deployed into a target vessel, where it expands and induces clot formation, effectively blocking blood flow. This device is particularly useful in managing vascular abnormalities such as aneurysms or arteriovenous malformations.
Clinical Applications
The Breezeway II is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to manage conditions like cerebral aneurysms, gastrointestinal bleeding, or peripheral vascular malformations. Patients benefiting from this device typically include those with vascular anomalies requiring minimally invasive intervention.
Indications for Use
The FDA indications for the Breezeway II involve its use in embolization procedures to occlude blood vessels. This is particularly relevant for patients with conditions such as aneurysms or arteriovenous malformations where blood flow needs to be controlled or stopped.
Practical Considerations
Clinicians should consider the sizing and compatibility of the Breezeway II with existing catheter systems. Proper technique in deploying the coil is crucial to ensure optimal placement and effectiveness. Familiarity with the device's deployment mechanism is recommended for successful outcomes.
Frequently Asked Questions
What is Breezeway II used for?
The Breezeway II is used for embolization procedures to occlude blood vessels and manage vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Breezeway II.
What are the FDA-cleared indications?
The device is indicated for embolization procedures to occlude blood vessels, particularly in cases of 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.