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aust steerable sheath
Centerpoint Systems
Summary: The Aust Steerable Sheath is a medical device used in interventional procedures to provide access and support for embolization coils. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K251051 ↗
Decision Date
April 30, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Aust Steerable Sheath was cleared through the FDA 510k pathway on April 30, 2025. 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 navigate through the vascular system to deliver embolization coils. Its steerability allows for precise positioning in complex vascular anatomy, enhancing procedural efficiency and safety. This device is particularly useful in procedures requiring high precision and control.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Aust Steerable Sheath is integral in procedures such as embolization of aneurysms or arteriovenous malformations. It is used in hospital settings, particularly in catheterization labs, and is suitable for adult patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for the Aust Steerable Sheath include its use in delivering embolization coils to treat vascular abnormalities. It is intended for patients with conditions like aneurysms or vascular malformations that require precise coil placement.
Practical Considerations
The Aust Steerable Sheath is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard embolization coils and requires familiarity with catheter navigation techniques. Clinicians should ensure proper training in its use to maximize its benefits.
Frequently Asked Questions
What is Aust Steerable Sheath used for?
It is used to deliver embolization coils in vascular procedures, providing access and support in complex anatomy.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular interventions.
What are the FDA-cleared indications?
It is indicated for delivering embolization coils to treat vascular abnormalities such as aneurysms and arteriovenous malformations.
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.