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super sheath xl introducer sheath
Togo Medikit
Summary: The Super Sheath XL Introducer Sheath is a medical device used to facilitate the insertion of catheters and other devices into blood vessels. It is primarily used by interventional radiologists and cardiologists during procedures like embolization.
FDA Clearance Information
Pathway
510K
Number
K060190 ↗
Decision Date
April 4, 2006
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Super Sheath XL Introducer Sheath was cleared through the FDA 510(k) pathway on April 4, 2006. Manufactured by Togo Medikit, it is a Class 2 device under product code DYB.
What It Is
The Super Sheath XL Introducer Sheath is a flexible tube designed to provide a conduit for the introduction of catheters and other medical devices into the vascular system. It typically includes a hemostatic valve to prevent blood loss during procedures. This device is crucial in minimally invasive procedures, allowing for safe and efficient access to the vascular system.
Clinical Applications
This introducer sheath is commonly used in interventional radiology and cardiology for procedures such as embolization, where precise catheter placement is necessary. It is particularly useful in settings that require vascular access, such as hospitals and specialized outpatient centers. Patients undergoing treatment for vascular conditions, such as aneurysms or arteriovenous malformations, may benefit from its use.
Indications for Use
The FDA-cleared indications for the Super Sheath XL Introducer Sheath include its use in facilitating the insertion of devices into blood vessels. It is suitable for patients requiring vascular interventions, particularly those involving embolization procedures.
Practical Considerations
The Super Sheath XL is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires, making it versatile for various procedures. Clinicians should be familiar with the device's insertion technique to ensure optimal outcomes.
Frequently Asked Questions
What is the Super Sheath XL Introducer Sheath used for?
It is used to facilitate the insertion of catheters and other medical devices into blood vessels during procedures like embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the insertion of devices into blood vessels, particularly during embolization procedures.
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.