đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a catheter or guidewire connector during interventional vascular procedures.
- Facilitate the introduction, manipulation, and withdrawal of guidewires and catheters.
- Provide a hemostatic, leak-resistant interface during procedures involving embolization devices such as coils.
Clinical Applications
- Connecting a catheter system to a guidewire or embolization delivery system.
- Supporting controlled placement of embolization coils during vascular occlusion procedures.
- Maintaining a sealed connection during catheter-based treatment of aneurysms, arteriovenous malformations, and other vascular abnormalities.
- Use in catheterization laboratories, interventional radiology suites, and operating rooms when compatible with the procedure equipment.
Practical Considerations
- Confirm compatibility with the catheter, guidewire, microcatheter, and embolization system before use.
- Select the appropriate connector size and configuration for the equipment; available sizes and specifications should be verified in the device labeling.
- Tighten the Touhy-Borst valve enough to limit blood or contrast leakage while avoiding excessive force that could impair guidewire movement or damage the catheter.
- Inspect connections for leaks, air, kinks, or damage before and during use.
- MRI safety is not established from the available record; consult the current manufacturer labeling before scanning a patient with the device in place.
Procedures that use this device
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.