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duoflo 6f
Argon Medical
Summary: The duoflo 6f is a venous stent used to support and maintain open veins. It is primarily used by interventional radiologists and vascular surgeons in procedures involving venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K833303 ↗
Decision Date
December 27, 1983
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The duoflo 6f was cleared by the FDA through the 510k pathway on December 27, 1983. It is manufactured by Argon Medical and classified as a Class 2 device under product code DQY.
What It Is
The duoflo 6f is a medical device designed as a venous stent, which is used to keep veins open in patients with venous obstructions. It is typically made from biocompatible materials that allow for integration with the vessel wall, providing structural support and improving blood flow. This device is crucial in maintaining patency in veins that are prone to collapse or blockage.
Clinical Applications
Clinically, the duoflo 6f is used in procedures to treat conditions such as deep vein thrombosis or chronic venous insufficiency. It is commonly deployed in interventional radiology suites or vascular surgery settings. The device is suitable for adult patients who present with venous blockages that require mechanical support to prevent re-occlusion.
Indications for Use
The FDA indications for the duoflo 6f include use in patients with venous obstructions needing stenting to maintain vessel patency. It is particularly indicated for those with conditions that cause narrowing or blockage of veins.
Practical Considerations
The duoflo 6f typically comes in various lengths and diameters to accommodate different patient anatomies and clinical needs. It is important to ensure compatibility with existing vascular access equipment and to follow precise deployment techniques to avoid complications such as migration or improper placement.
Frequently Asked Questions
What is duoflo 6f used for?
The duoflo 6f is used to maintain open veins in patients with venous obstructions, preventing collapse or blockage.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the duoflo 6f in procedures involving venous stenting.
What are the FDA-cleared indications?
The duoflo 6f is indicated for use in patients with venous obstructions requiring stenting to maintain vessel patency.
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.