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y-adapter w thouy borst
Angeion
Summary: The Y-Adapter w Thouy Borst by Angeion is a Class 2 medical device used in interventional radiology and cardiology for procedures involving embolization coils. It is primarily used by specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K895580 ↗
Decision Date
April 30, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Y-Adapter w Thouy Borst was cleared through the FDA 510(k) pathway on April 30, 1990. Manufactured by Angeion, it is classified as a Class 2 device under product code DYB.
What It Is
The Y-Adapter w Thouy Borst is a medical device designed to facilitate the delivery and deployment of embolization coils during interventional procedures. It acts as a connector that allows for the simultaneous passage of guidewires and catheters, providing a secure and leak-proof interface. This device is essential in maintaining hemostasis while allowing for the manipulation of interventional tools.
Clinical Applications
This device is commonly used in interventional radiology and cardiology, particularly in procedures aimed at occluding blood vessels to prevent hemorrhage or to treat vascular malformations. It is frequently employed in settings such as catheterization labs and operating rooms. The typical patient population includes those with aneurysms, arteriovenous malformations, or other vascular abnormalities.
Indications for Use
The Y-Adapter w Thouy Borst is indicated for use in procedures requiring the deployment of embolization coils. It is suitable for patients undergoing treatment for vascular conditions where controlled occlusion of blood vessels is necessary.
Practical Considerations
Clinicians should be aware of the compatibility of the Y-Adapter with various catheter sizes and types. Proper technique is essential to ensure a secure fit and prevent leaks during procedures. Familiarity with the device's operation can enhance procedural efficiency and safety.
Frequently Asked Questions
What is the Y-Adapter w Thouy Borst used for?
It is used to facilitate the delivery of embolization coils during interventional procedures, maintaining hemostasis while allowing for the manipulation of guidewires and catheters.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device in procedures involving vascular occlusion.
What are the FDA-cleared indications?
The device is indicated for use in procedures that require the deployment of embolization coils to treat vascular conditions.
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.