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aust steerable sheath
Centerpoint Systems
Summary: The Aust Steerable Sheath is a medical device used primarily in interventional radiology for embolization procedures. It is utilized by specialists to navigate and deliver embolization coils with precision.
FDA Clearance Information
Pathway
510K
Number
K240829 ↗
Decision Date
May 1, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Aust Steerable Sheath was cleared through the FDA 510k pathway on May 1, 2024. Manufactured by Centerpoint Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The Aust Steerable Sheath is a flexible, steerable catheter designed to facilitate the delivery of embolization coils in vascular procedures. Its steerability allows for precise navigation through complex vascular anatomy, enhancing the accuracy and safety of embolization procedures. This device is particularly useful in reaching difficult-to-access areas within the vasculature.
Clinical Applications
Commonly used in interventional radiology, the Aust Steerable Sheath is employed during embolization procedures to treat conditions such as aneurysms or arteriovenous malformations. It is particularly beneficial in settings where precise coil placement is critical, such as in neurovascular or peripheral vascular interventions. The device is suitable for adult and pediatric patient populations requiring minimally invasive vascular treatment.
Indications for Use
The FDA has cleared the Aust Steerable Sheath for use in delivering embolization coils, which are used to block blood flow to specific areas, such as in the treatment of aneurysms or vascular malformations. It is indicated for patients who require targeted embolization therapy.
Practical Considerations
The Aust Steerable Sheath typically comes in various sizes to accommodate different vascular anatomies and is compatible with standard embolization coils. Clinicians should be familiar with catheter navigation techniques to optimize the device's steerability and ensure precise coil deployment.
Frequently Asked Questions
What is the Aust Steerable Sheath used for?
The Aust Steerable Sheath is used for delivering embolization coils in vascular procedures, aiding in the treatment of conditions like aneurysms.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in procedures requiring precise coil placement.
What are the FDA-cleared indications?
The device is cleared for use in delivering embolization coils to block blood flow in targeted vascular areas, such as in treating 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.