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chariot guiding sheath
Boston Scientific
Summary: The Chariot Guiding Sheath is a medical device used to facilitate the delivery of interventional tools during endovascular procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K150186 ↗
Decision Date
June 5, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Chariot Guiding Sheath was cleared via the FDA 510(k) pathway on June 5, 2015, by Boston Scientific. It is a Class 2 medical device under product code DYB.
What It Is
The Chariot Guiding Sheath is a flexible, tubular device designed to provide a conduit for the introduction of catheters and other interventional devices into the vascular system. It is used to guide and support these devices during procedures, ensuring precise placement and stability. The sheath is typically made of biocompatible materials and may include features such as a hydrophilic coating to ease insertion.
Clinical Applications
The Chariot Guiding Sheath is commonly used in endovascular procedures such as embolization, where it helps in the precise placement of embolization coils. It is utilized in specialties like interventional radiology and cardiology, often in hospital settings. The device is suitable for a range of patient populations requiring vascular interventions, including those with aneurysms or vascular malformations.
Indications for Use
The FDA indications for the Chariot Guiding Sheath include its use in facilitating the delivery of embolization coils and other interventional devices. It is intended for patients undergoing procedures to treat vascular conditions.
Practical Considerations
The Chariot Guiding Sheath comes in various sizes to accommodate different vascular anatomies and procedural needs. It is compatible with a range of interventional devices and requires careful handling to maintain sterility and function. Clinicians should be familiar with the specific insertion techniques to optimize performance.
Frequently Asked Questions
What is the Chariot Guiding Sheath used for?
The Chariot Guiding Sheath is used to facilitate the delivery of catheters and interventional devices during vascular procedures.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use the Chariot Guiding Sheath.
What are the FDA-cleared indications?
The Chariot Guiding Sheath is indicated for use in facilitating the delivery of embolization coils and other interventional devices during vascular 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.