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aust steerable sheath
Centerpoint Systems
Summary: The Aust Steerable Sheath is a medical device used in interventional radiology and cardiology for precise catheter navigation during embolization procedures. It is primarily utilized by interventional specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K242106 ↗
Decision Date
October 4, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Aust Steerable Sheath, manufactured by Centerpoint Systems, received FDA clearance through the 510(k) pathway on October 4, 2024. It is classified as a Class 2 device under product code DYB.
What It Is
The Aust Steerable Sheath is a flexible, steerable catheter sheath designed to facilitate the navigation and placement of catheters during minimally invasive procedures. Its steerability allows for enhanced maneuverability and precision in accessing vascular structures, making it particularly useful in complex anatomical situations. The device is constructed to provide support and stability for the delivery of embolization coils or other therapeutic devices.
Clinical Applications
This device is commonly used in interventional radiology and cardiology, particularly in procedures involving embolization of vascular abnormalities such as aneurysms or arteriovenous malformations. It is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario. The Aust Steerable Sheath is often employed in hospital catheterization labs and interventional suites, where precise catheter control is critical.
Indications for Use
The FDA-cleared indications for the Aust Steerable Sheath include its use in procedures requiring the delivery of embolization coils. It is intended for patients with conditions that necessitate precise vascular access and navigation during interventional procedures.
Practical Considerations
The Aust Steerable Sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and embolization devices. Clinicians should be familiar with the device's steering mechanism to maximize its effectiveness during procedures.
Frequently Asked Questions
What is the Aust Steerable Sheath used for?
The Aust Steerable Sheath is used for navigating and placing catheters during embolization procedures, particularly in interventional radiology and cardiology.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is cleared for use in procedures requiring the delivery of embolization coils for vascular abnormalities.
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.