📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Delivery of embolization coils during vascular embolization procedures.
- Use when a steerable sheath is needed to access and support coil delivery through challenging vascular anatomy.
Clinical Applications
- Catheter-based delivery of embolization coils to a targeted blood vessel.
- Embolization of selected aneurysms or pseudoaneurysms when coil treatment is appropriate.
- Embolization of selected arteriovenous malformations or other vascular abnormalities when coils are indicated.
- Coil embolization in peripheral or neurovascular procedures, as determined by the treating specialist and the specific device labeling.
Practical Considerations
- The available sizes, working length, steerability, and inner diameter should be matched to the patient's anatomy, the access route, and the embolization coil system.
- The device is typically introduced through vascular access under fluoroscopic or other appropriate imaging guidance, with local anesthesia and, when needed, moderate sedation or general anesthesia.
- Compatibility with the intended embolization coils, guidewires, catheters, contrast agents, and other procedural equipment must be confirmed before use.
- MRI safety information is device- and model-specific. The applicable FDA labeling and manufacturer instructions should be reviewed before an MRI examination.
- Potential concerns include vascular injury, bleeding, thrombosis, infection, contrast reaction, embolization to an unintended location, and difficulty removing or steering the device. Contraindications and warnings in the current instructions for use apply.
Procedures that use this device
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.