đź“‹ FDA Reference
scorpion stylet portal vein access set scorpion needle portal vein access set
Argon Medical Devices
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
510K
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.
Clinical Applications
This device is commonly used in interventional radiology, particularly for procedures involving the liver such as portal vein embolization. It is utilized in hospital settings, often by radiologists or interventional specialists, to treat conditions like portal hypertension or to prepare patients for liver surgery. The device is suitable for adult patients who require vascular interventions involving the portal vein.
Indications for Use
The FDA indications suggest that this device is intended for use in accessing the portal vein for procedures that may involve embolization. It is suitable for patients who need interventions related to liver circulation issues.
Practical Considerations
The Scorpion Stylet Portal Vein Access Set typically comes in various sizes to accommodate different patient anatomies. It is compatible with standard embolization coils and requires familiarity with vascular access techniques. Clinicians should ensure proper training in its use to maximize effectiveness and safety.
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.