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atrium medical corporation clearway rx catheter
Atrium Medical
Summary: The Atrium Medical ClearWay RX Catheter is a device used primarily for venous stenting. It is FDA-cleared and has been studied in two clinical trials, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway
510K
Number
K061680 ↗
Decision Date
December 15, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Atrium Medical ClearWay RX Catheter was cleared by the FDA via the 510k pathway on December 15, 2006. It is manufactured by Atrium Medical and classified as a Class 2 device under product code DQY.
What It Is
The ClearWay RX Catheter is designed for use in venous stenting procedures. It facilitates the delivery of therapeutic agents directly to the site of vascular lesions, aiming to improve outcomes in vascular interventions.
Clinical Applications
This catheter is commonly used in scenarios requiring precise delivery of medication to vascular lesions, such as in cases of myocardial infarction or other vascular occlusions. It is particularly useful in interventional cardiology settings.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov, focusing on the ClearWay RX Catheter. These studies do not provide detailed outcomes or safety data, indicating a need for further research.
Reported Outcomes
Published studies report limited data on the efficacy of the ClearWay RX Catheter. Specific outcomes from the available studies are not detailed, highlighting a gap in comprehensive efficacy reporting.
Safety Profile
Reported complications include a lack of detailed safety data from the existing studies. Further research is needed to establish a comprehensive safety profile for the device.
Evidence Limitations
The current evidence is limited by the lack of detailed outcomes and safety data from the available studies. Further research is necessary to fully understand the efficacy and safety of the ClearWay RX Catheter.
Frequently Asked Questions
What are the clinical indications for Atrium Medical ClearWay RX Catheter?
The device is indicated for use in venous stenting procedures, particularly in delivering therapeutic agents to vascular lesions.
What outcomes have been reported in clinical studies?
Specific outcomes from the available studies are not detailed, indicating a need for further research.
What complications have been reported?
The studies do not provide detailed safety data, highlighting the need for further investigation into potential complications.
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.