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burron cardiovascular angestat tm
B. Braun Medical
Summary: The Burron Cardiovascular Angestat TM is a medical device used for embolization procedures, primarily by interventional radiologists and cardiologists. It is designed to occlude blood vessels to control bleeding or reduce blood flow to specific areas.
FDA Clearance Information
Pathway
510K
Number
K931743 ↗
Decision Date
November 2, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Burron Cardiovascular Angestat TM was cleared through the FDA 510(k) pathway on November 2, 1993. It is manufactured by B. Braun Medical and classified as a Class 2 device under product code DYB.
What It Is
The Burron Cardiovascular Angestat TM is an embolization coil system used to occlude blood vessels. It works by being placed into a vessel via a catheter, where it expands and blocks blood flow. This device is crucial in procedures requiring the reduction of blood flow to specific areas, such as in treating aneurysms or controlling hemorrhages.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings. It is employed in procedures like treating cerebral aneurysms, gastrointestinal bleeding, or pre-surgical tumor devascularization. The device is suitable for adult and pediatric patients, depending on the clinical scenario and vessel size.
Indications for Use
The FDA indications for the Burron Cardiovascular Angestat TM involve its use in embolization procedures. Clinically, this means it is used to block blood vessels in cases where reducing blood flow can aid in treatment, such as stopping bleeding or managing vascular malformations.
Practical Considerations
Clinicians should consider the size of the vessel and the specific clinical scenario when selecting the appropriate coil size. Compatibility with existing catheter systems should be verified, and proper technique in deployment is crucial to ensure effective vessel occlusion.
Frequently Asked Questions
What is Burron Cardiovascular Angestat TM used for?
It is used for embolization procedures to occlude blood vessels and control blood flow.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device.
What are the FDA-cleared indications?
The device is indicated for embolization procedures to occlude blood vessels.
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.