đź“‹ FDA Reference
traveler38 0 038 stylet portal vein access set traveler21 21ga needle portal vein access set traveler16 16ga needle portal vein access set
Argon Medical Devices
Summary: The Traveler stylet and needle sets are medical devices used for portal vein access, primarily by interventional radiologists. They facilitate procedures such as embolization.
FDA Clearance Information
Pathway
510K
Number
K201489 ↗
Decision Date
December 22, 2020
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Traveler stylet and needle sets were cleared through the FDA 510(k) pathway on December 22, 2020. Manufactured by Argon Medical Devices, these are Class 2 devices.
What It Is
The Traveler stylet and needle sets are designed for portal vein access. They include various gauge needles and a stylet, which are essential tools in vascular procedures. These devices enable clinicians to access the portal vein safely and efficiently, which is crucial for interventions like embolization.
Clinical Applications
These devices are commonly used in interventional radiology for procedures involving the portal vein, such as embolization of liver tumors. They are typically used in hospital settings by specialists trained in vascular access techniques. Patients undergoing these procedures often have conditions like liver cancer or portal hypertension.
Indications for Use
The FDA-cleared indications for the Traveler sets involve accessing the portal vein, which is critical for procedures like embolization. These devices are intended for patients requiring vascular interventions in the portal venous system.
Practical Considerations
The Traveler sets come in different sizes, including 21ga and 16ga needles, allowing for flexibility depending on patient anatomy and procedure requirements. Compatibility with standard embolization coils and catheters should be considered. Proper technique is essential to minimize complications.
Frequently Asked Questions
What is the Traveler stylet and needle sets used for?
They are used for accessing the portal vein during procedures such as embolization.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use these devices.
What are the FDA-cleared indications?
The devices are indicated for accessing the portal vein, facilitating procedures like 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.