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14f isleeve introducer set
Boston Scientific
Summary: The 14f isleeve introducer set by Boston Scientific is a medical device used primarily in interventional radiology and cardiology for vascular access during embolization procedures. It is typically used by specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K233503 ↗
Decision Date
November 30, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The 14f isleeve introducer set by Boston Scientific was cleared via the FDA 510k pathway on November 30, 2023. It is classified as a Class 2 device under product code DYB.
What It Is
The 14f isleeve introducer set is a medical device designed to facilitate vascular access during interventional procedures. It consists of a sheath and dilator that allow for the introduction of catheters and other instruments into the vascular system. This device is particularly useful in procedures requiring precise and stable access to blood vessels, such as embolization.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures involving embolization coils. It is suitable for use in hospital settings where vascular access is required, such as during the treatment of aneurysms or arteriovenous malformations. The device is used by interventional radiologists and cardiologists to ensure safe and effective access to the vascular system, particularly in adult patients.
Indications for Use
The 14f isleeve introducer set is indicated for use in patients requiring vascular access for embolization procedures. It is suitable for conditions where precise delivery of embolization coils is necessary, such as in the treatment of vascular abnormalities.
Practical Considerations
The 14f isleeve introducer set is typically available in various lengths to accommodate different patient anatomies and procedural requirements. It is compatible with a range of embolization coils and catheters. Clinicians should be familiar with vascular access techniques and ensure compatibility with other procedural equipment.
Frequently Asked Questions
What is the 14f isleeve introducer set used for?
It is used for vascular access during embolization procedures, allowing for the introduction of catheters and embolization coils.
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 vascular access in embolization procedures, particularly for delivering embolization coils in the treatment of vascular abnormalities.
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.