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10f sheath and dilator set
Argon Medical Devices
Summary: The 10f sheath and dilator set by Argon Medical Devices is used for vascular access in interventional procedures. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K233432 ↗
Decision Date
December 8, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The 10f sheath and dilator set was cleared through the FDA 510(k) pathway on December 8, 2023. It is manufactured by Argon Medical Devices and classified as a Class 2 device under product code DYB.
What It Is
The 10f sheath and dilator set is a medical device designed to facilitate vascular access during interventional procedures. The sheath provides a stable conduit for the introduction of catheters and other instruments into the vascular system, while the dilator aids in vessel entry by gradually expanding the vessel diameter. This device is essential for procedures requiring precise and reliable vascular access.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures such as embolization, stent placement, and other endovascular interventions. The sheath and dilator set is particularly useful in patients requiring repeated access to the vascular system, such as those undergoing treatment for vascular anomalies or chronic conditions.
Indications for Use
The FDA indications suggest this device is intended for use in procedures requiring vascular access, particularly in the context of embolization-coils. It is suitable for patients needing precise and stable access to blood vessels for therapeutic interventions.
Practical Considerations
The 10f sheath and dilator set is typically available in various lengths to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires, making it versatile for various interventional techniques. Clinicians should ensure proper sizing and technique to minimize complications.
Related Literature
The linked study investigated the feasibility of creating a direct intrahepatic portacaval shunt using a PTFE-covered stent-graft in a swine model, guided by intravascular ultrasound. The study demonstrated the potential for this technique in clinical settings, although it was limited by its small sample size and the preliminary nature of the findings. The initial clinical results suggested promise but highlighted the need for further research to establish efficacy and safety.
Frequently Asked Questions
What is the 10f sheath and dilator set used for?
It is used for providing vascular access in interventional procedures, allowing for the introduction of catheters and other instruments into the vascular system.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, particularly in the context of embolization-coils.
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.