đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in vascular procedures that require the delivery of embolization coils.
- Facilitation of access to and delivery of embolic material within the vasculature.
Clinical Applications
- Delivery of embolization coils for treatment of selected aneurysms and pseudoaneurysms.
- Catheter-based embolization of abnormal blood vessels when coil delivery is required.
- Support of controlled embolic-material placement in peripheral or visceral vascular procedures.
Practical Considerations
- The appropriate sheath size and length depend on the access site, target vessel, catheter system and embolic device being used.
- The device should be handled under fluoroscopic or other appropriate imaging guidance to confirm position and reduce the risk of vessel injury.
- Compatibility with the planned microcatheter, guidewire and embolization coil system must be confirmed before use.
- The supplied FDA record does not establish MRI safety; MRI conditions should be confirmed from the current product labeling or manufacturer.
- As with other vascular access devices, clinicians should consider bleeding, infection, thrombosis, vasospasm, dissection, perforation and non-target embolization risks.
Procedures that use this device
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.