đź“‹ FDA Reference
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Argon Medical Devices
Summary: The Traveler Portal Vein Access Set is used for accessing the portal vein, primarily in interventional radiology procedures. It is used by clinicians specializing in vascular access and embolization.
FDA Clearance Information
Pathway
510K
Number
K213638 ↗
Decision Date
December 10, 2021
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Traveler Portal Vein Access Set by Argon Medical Devices was cleared through the FDA 510(k) pathway on December 10, 2021. It is a Class 2 medical device.
What It Is
The Traveler Portal Vein Access Set is a medical device designed for accessing the portal vein. It includes a stylet and needles of varying gauges to facilitate vascular access. This device is crucial in procedures requiring precise entry into the portal vein, often for diagnostic or therapeutic purposes.
Clinical Applications
This device is commonly used in interventional radiology for procedures such as portal vein embolization or transjugular intrahepatic portosystemic shunt (TIPS) creation. It is typically used in hospital settings by interventional radiologists or vascular surgeons. Patients with conditions like portal hypertension or liver disease may benefit from procedures utilizing this device.
Indications for Use
The device is indicated for use in accessing the portal vein, which is essential in procedures like embolization or shunt placement. It is suitable for patients requiring vascular interventions related to liver or portal vein conditions.
Practical Considerations
The set includes needles of 21 and 16 gauge, allowing for flexibility depending on the procedure and patient anatomy. Compatibility with other vascular access tools should be considered, and clinicians should be familiar with ultrasound or fluoroscopic guidance techniques for optimal use.
Frequently Asked Questions
What is the Traveler Portal Vein Access Set used for?
It is used for accessing the portal vein in procedures like embolization or shunt placement.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for accessing the portal vein for vascular interventions.
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.