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aries tapered sheath
Aries Medical
Summary: The Aries Tapered Sheath is a medical device used primarily in interventional radiology for procedures involving embolization coils. It is utilized by clinicians to facilitate the delivery of embolic materials in vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K870189 ↗
Decision Date
March 16, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Aries Tapered Sheath was cleared through the FDA 510(k) pathway on March 16, 1987. Manufactured by Aries Medical, it is classified as a Class II device under product code DYB.
What It Is
The Aries Tapered Sheath is a specialized catheter designed to assist in the delivery of embolization coils during vascular procedures. Its tapered design allows for smooth navigation through the vasculature, minimizing trauma to the vessel walls. This device is essential in providing access to target sites within the vascular system, ensuring precise placement of embolic materials.
Clinical Applications
Commonly used in interventional radiology, the Aries Tapered Sheath is employed in procedures such as embolization to treat aneurysms or arteriovenous malformations. It is particularly useful in settings where precise delivery of embolic agents is critical, such as in neurovascular or peripheral vascular interventions. The device is suitable for adult patients requiring embolization therapy.
Indications for Use
The Aries Tapered Sheath is indicated for use in procedures requiring the delivery of embolization coils, such as treating vascular abnormalities like aneurysms. It is designed to facilitate the safe and effective placement of embolic materials in the vasculature.
Practical Considerations
The Aries Tapered Sheath typically comes in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of embolic materials and requires careful handling to ensure optimal performance during procedures.
Frequently Asked Questions
What is the Aries Tapered Sheath used for?
It is used for delivering embolization coils during vascular procedures, particularly in interventional radiology.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in procedures involving embolization.
What are the FDA-cleared indications?
The device is indicated for use in delivering embolization coils to treat vascular abnormalities 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.