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14f isleeve introducer set
Boston Scientific
Summary: The 14f isleeve introducer set is a medical device used primarily in interventional radiology and cardiology for facilitating the insertion of embolization coils. It is typically used by specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K230051 ↗
Decision Date
February 3, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The 14f isleeve introducer set was cleared through the FDA 510k pathway on February 3, 2023. Manufactured by Boston Scientific, it is classified as a Class 2 device under product code DYB.
What It Is
The 14f isleeve introducer set is a specialized medical device designed to aid in the insertion of embolization coils. It consists of a sheath and dilator that provide a conduit for the safe and efficient delivery of coils into the vascular system. This device is crucial in procedures requiring precise placement of coils to occlude blood vessels, often used to treat aneurysms or prevent bleeding.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures, particularly in the embolization of blood vessels. It is essential in treating conditions such as aneurysms, arteriovenous malformations, and other vascular abnormalities. The introducer set is typically utilized in hospital settings, including catheterization labs and operating rooms, by specialists such as interventional radiologists and cardiologists.
Indications for Use
The FDA indications for the 14f isleeve introducer set involve its use in procedures requiring the delivery of embolization coils. It is indicated for patients needing vascular occlusion to treat or prevent conditions like aneurysms or to control bleeding.
Practical Considerations
The 14f isleeve introducer set is designed to be compatible with a range of embolization coils and is typically available in various lengths to accommodate different patient anatomies. Clinicians should ensure proper sizing and compatibility with other procedural equipment to optimize outcomes and minimize complications.
Frequently Asked Questions
What is the 14f isleeve introducer set used for?
The 14f isleeve introducer set is used for facilitating the insertion of embolization coils during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for procedures requiring the delivery of embolization coils to occlude blood vessels, such as treating aneurysms or controlling bleeding.
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.