đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Delivery of embolization coils during vascular interventional procedures.
- Use in the treatment of vascular abnormalities requiring coil embolization, according to the cleared device labeling.
Clinical Applications
- Catheter-based delivery of embolization coils to selected blood vessels.
- Coil embolization of aneurysms when embolization is clinically indicated.
- Coil embolization of arteriovenous malformations or other vascular abnormalities when included in the treatment plan.
Practical Considerations
- The device is available in different sizes and configurations; the appropriate choice depends on vessel anatomy, access route and the embolization coil system being used.
- It requires fluoroscopic or other appropriate imaging guidance and should be handled by clinicians trained in catheter-based vascular procedures.
- Compatibility with the intended embolization coils and other procedural equipment should be confirmed before use.
- The record provided does not establish MRI safety. MRI compatibility should be verified in the current manufacturer labeling before scanning a patient with the device in place.
- Contraindications, warnings, access-site requirements and maximum indwelling time should be checked in the current instructions for use.
Procedures that use this device
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.