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modification to outback catheter
Lumend
Summary: The modification to the Outback Catheter by Lumend is a Class 2 device used primarily for venous stenting. It has been FDA-cleared via the 510k pathway. Current evidence includes two studies focusing on peripheral arteries above and below the knee.
FDA Clearance Information
Pathway
510K
Number
K032298 ↗
Decision Date
August 26, 2003
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 August 26, 2003. 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 facilitates the placement of stents in peripheral arteries, particularly those above and below the knee.
Clinical Applications
This device is commonly used in clinical settings for patients requiring venous stenting in peripheral arteries. It is particularly applicable in scenarios involving peripheral artery disease where stent placement is necessary.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov, focusing on peripheral arteries above and below the knee. The studies are ongoing, and specific details on sample size and outcomes are not yet available.
Reported Outcomes
Published studies report ongoing investigations into the efficacy of the device for stenting in peripheral arteries. However, specific outcomes have not been detailed in the available evidence.
Safety Profile
Reported complications include potential adverse events related to venous stenting procedures. Specific safety data from the studies are not yet available.
Evidence Limitations
The current evidence is limited by the lack of published outcomes and safety data. 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 from the studies are not yet available as the research is ongoing.
What complications have been reported?
Safety data from the studies are not yet available, but potential complications are related to venous stenting procedures.
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.