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aries taperseal tm sheath
Aries Medical
Summary: The Aries Taperseal TM Sheath is a medical device used primarily in vascular procedures to facilitate the introduction of embolization coils. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K903442 ↗
Decision Date
August 23, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Aries Taperseal TM Sheath was cleared through the FDA 510(k) pathway on August 23, 1990. Manufactured by Aries Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Aries Taperseal TM Sheath is a specialized introducer sheath designed to provide a smooth transition for catheters and other instruments into the vascular system. Its tapered design minimizes trauma to the vessel wall, reducing the risk of complications during procedures. This device is particularly useful in procedures requiring the placement of embolization coils, where precise and controlled access is critical.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Aries Taperseal TM Sheath is employed during embolization procedures to treat aneurysms or block abnormal blood vessels. It is suitable for use in hospital settings, particularly in catheterization labs, and is often used in adult patients requiring vascular interventions. The sheath's design facilitates the safe and efficient delivery of embolization materials.
Indications for Use
The Aries Taperseal TM Sheath is indicated for use in procedures requiring vascular access, particularly those involving the placement of embolization coils. It is designed to assist in the treatment of conditions such as aneurysms or arteriovenous malformations by providing a conduit for therapeutic devices.
Practical Considerations
The sheath is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of guidewires and catheters, making it versatile for various interventions. Clinicians should ensure proper sizing and compatibility with other devices to optimize procedural outcomes.
Frequently Asked Questions
What is the Aries Taperseal TM Sheath used for?
It is used to facilitate the introduction of embolization coils and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in vascular access procedures, particularly those involving embolization to treat aneurysms or abnormal blood vessels.
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.