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15f isleeve introducer set 14f isleeve introducer set
Boston Scientific
Summary: The 15f and 14f isleeve introducer sets by Boston Scientific are medical devices used to facilitate the introduction of embolization coils during interventional procedures. They are typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K191871 ↗
Decision Date
August 7, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The 15f and 14f isleeve introducer sets were cleared through the FDA 510(k) pathway on August 7, 2019. Manufactured by Boston Scientific, these devices are classified as Class 2 under product code DYB.
What It Is
The 15f and 14f isleeve introducer sets are medical devices designed to aid in the placement of embolization coils. These introducers provide a conduit through which coils can be delivered to target sites within the vascular system. They are essential in ensuring the safe and precise delivery of coils during embolization procedures, which are used to block blood flow to certain areas, such as aneurysms or tumors.
Clinical Applications
These introducer sets are commonly used in interventional radiology and cardiology settings for procedures involving embolization. They are particularly useful in treating conditions like arteriovenous malformations, aneurysms, and certain types of tumors. The devices are used in hospital settings, often in catheterization labs, and are suitable for adult and pediatric patient populations requiring vascular interventions.
Indications for Use
The FDA indications for the 15f and 14f isleeve introducer sets involve their use in procedures requiring the delivery of embolization coils. These devices are intended for patients needing vascular occlusion to treat conditions such as aneurysms or to control bleeding.
Practical Considerations
The introducer sets come in different sizes, 15f and 14f, to accommodate various procedural needs. They are compatible with a range of embolization coils and require careful technique to ensure proper placement and function. Clinicians should be familiar with the specific handling and insertion techniques for optimal outcomes.
Frequently Asked Questions
What is the 15f & 14f isleeve introducer set used for?
It is used to facilitate the delivery of embolization coils during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the delivery of embolization coils to treat vascular conditions such as aneurysms.
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.