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Scorpion Stylet Portal Vein Access Set Scorpion Needle Portal Vein Access Set
Summary: The Scorpion Stylet Portal Vein Access Set is a medical device used for accessing the portal vein, primarily in interventional radiology. It is used by healthcare professionals to facilitate procedures such as embolization.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K202141 ↗
Decision Date ?
January 15, 2021
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Scorpion Stylet Portal Vein Access Set was cleared through the FDA 510(k) pathway on January 15, 2021. Manufactured by Argon Medical Devices, it is classified as a Class 2 device under product code DYB.
What It Is
The Scorpion Stylet Portal Vein Access Set is designed to provide access to the portal vein, a major vessel in the liver. It consists of a stylet and needle system that allows for precise navigation and access. This device is particularly useful in procedures requiring portal vein embolization, where accurate placement is crucial.
FDA-Cleared Indications
- Access to the portal vein for diagnostic or interventional procedures.
- Portal venous access when a needle-and-stylet system is clinically appropriate.
- Use by qualified healthcare professionals under appropriate imaging guidance.
Clinical Applications
- Percutaneous portal vein access for portal vein embolization.
- Portal venous access for other procedures that require entry into the portal circulation.
- Interventional radiology procedures involving the liver and portal venous system.
Practical Considerations
- The device should be used only by clinicians trained in percutaneous vascular access and portal venous interventions.
- Ultrasound, fluoroscopy, CT, or another appropriate imaging method may be used to guide access, depending on the procedure and patient anatomy.
- Available needle and stylet configurations should be selected according to the patient’s anatomy, access route, and procedural requirements; exact sizes should be confirmed in the current manufacturer instructions for use.
- The device is generally used as a single-use access set; it is not intended to remain implanted after the procedure.
- MRI safety and conditional-use information should be confirmed in the current product labeling. Do not assume MRI compatibility from the device name alone.
Procedures that use this device
Frequently Asked Questions
What is the Scorpion Stylet Portal Vein Access Set used for?
It is used for accessing the portal vein to facilitate procedures like embolization in the liver.
What specialties typically use this device?
Interventional radiologists and specialists in vascular procedures commonly use this device.
What are the FDA-cleared indications?
It is indicated for accessing the portal vein, particularly for procedures involving embolization.
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.