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a b korkor medical skinnysafe introducer sheath
A.B. Korkor Medical
Summary: The SkinnySafe Introducer Sheath by A.B. Korkor Medical is a device used in vascular procedures to facilitate the introduction of catheters or other instruments. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K092097 ↗
Decision Date
May 6, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The SkinnySafe Introducer Sheath was cleared through the FDA 510(k) pathway on May 6, 2010. It is manufactured by A.B. Korkor Medical and classified as a Class 2 device under product code DYB.
What It Is
The SkinnySafe Introducer Sheath is a medical device designed to provide a conduit for the insertion of catheters and other devices into the vascular system. It features a thin, flexible design that minimizes trauma to the vessel wall during insertion. The sheath is typically used in procedures requiring vascular access, such as angiography or the placement of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings, particularly during procedures that require precise vascular access. It is suitable for use in hospitals and specialized clinics, catering to adult and pediatric patients needing embolization or other vascular interventions. The sheath's design allows for smooth insertion and removal, reducing the risk of complications.
Indications for Use
The SkinnySafe Introducer Sheath is indicated for use in patients requiring vascular access for the delivery of embolization coils or other therapeutic devices. It is suitable for conditions where minimally invasive access to the vascular system is necessary.
Practical Considerations
The SkinnySafe Introducer Sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires, ensuring versatility in clinical use. Proper technique during insertion is crucial to minimize vessel trauma and ensure successful device deployment.
Frequently Asked Questions
What is the SkinnySafe Introducer Sheath used for?
The SkinnySafe Introducer Sheath is used to facilitate the introduction of catheters and other devices into the vascular system, often during procedures like angiography or embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the SkinnySafe Introducer Sheath during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for the delivery of embolization coils or other therapeutic devices.
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.