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modification to outback catheter
Lumend
Summary: The modification to the Outback Catheter by Lumend is a device used in venous stenting procedures. It is FDA-cleared under 510k pathway. Current evidence includes two studies focusing on peripheral arteries above and below the knee.
FDA Clearance Information
Pathway
510K
Number
K043534 ↗
Decision Date
January 21, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The modification to the Outback Catheter was cleared by the FDA through the 510k pathway on January 21, 2005. It is manufactured by Lumend and classified as a Class 2 device under product code DQY.
What It Is
The modification to the Outback Catheter is a medical device designed for use in venous stenting procedures. It assists in the placement of stents within peripheral arteries, particularly in challenging anatomical locations.
Clinical Applications
This device is commonly used in procedures involving the placement of stents in peripheral arteries, both above and below the knee. It is particularly useful in cases where traditional catheterization techniques are difficult to apply.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov, focusing on peripheral arteries above and below the knee. These studies are ongoing, and specific outcomes and safety data have not been published yet.
Reported Outcomes
Published studies report limited data on the efficacy of the modification to the Outback Catheter. As the studies are ongoing, specific outcomes related to the device's performance in stenting procedures are not yet available.
Safety Profile
Reported complications include limited information as the studies are still in progress. Detailed safety data and adverse event rates are not yet published.
Evidence Limitations
The current evidence is limited by the lack of published outcomes and safety data from the ongoing studies. Further research is needed to establish comprehensive efficacy and safety profiles for the device.
Frequently Asked Questions
What are the clinical indications for modification to outback catheter?
The device is indicated for use in venous stenting procedures, particularly in peripheral arteries above and below the knee.
What outcomes have been reported in clinical studies?
Specific findings are not yet available as the studies are ongoing.
What complications have been reported?
Safety data is currently limited, with no specific complications reported in the ongoing studies.
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.