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endologix visiflex dual lumen catheter
Endologix
Summary: The Endologix Visiflex Dual Lumen Catheter is a medical device used primarily in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to facilitate the placement of stents in venous pathways.
FDA Clearance Information
Pathway
510K
Number
K080360 ↗
Decision Date
April 8, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Endologix Visiflex Dual Lumen Catheter was cleared through the FDA 510(k) pathway on April 8, 2008. It is manufactured by Endologix and classified as a Class II medical device.
What It Is
The Endologix Visiflex Dual Lumen Catheter is a specialized catheter designed for use in venous stenting procedures. It features dual lumens, which allow for simultaneous guidewire and contrast media passage, enhancing procedural efficiency. The catheter is constructed to provide flexibility and support during navigation through venous anatomy, facilitating precise stent placement.
Clinical Applications
This device is commonly used in procedures involving the placement of stents within venous structures, such as in cases of venous obstructions or insufficiencies. Interventional radiologists and vascular surgeons employ this catheter in hospital settings, particularly in catheterization labs. It is suitable for adult patients requiring venous stenting due to conditions like deep vein thrombosis or chronic venous insufficiency.
Indications for Use
The FDA-cleared indications for the Endologix Visiflex Dual Lumen Catheter include its use in facilitating the placement of stents in venous pathways. It is intended for patients who require intervention to address venous obstructions or to improve venous blood flow.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and contrast media used in venous interventions. Clinicians should be familiar with catheter handling techniques to optimize performance and patient outcomes.
Frequently Asked Questions
What is the Endologix Visiflex Dual Lumen Catheter used for?
It is used for facilitating the placement of stents in venous pathways, particularly in cases of venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in venous stenting procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of stents in venous pathways to address obstructions or improve venous blood flow.
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.