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cardiac supply tray
Deroyal Industries
Summary: The cardiac supply tray by Deroyal Industries is a device used in venous stent procedures. It is FDA 510k cleared and linked to 11 studies, providing insights into its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K842645 ↗
Decision Date
August 27, 1984
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The cardiac supply tray was cleared through the FDA 510k pathway on August 27, 1984. Manufactured by Deroyal Industries, it is classified as a Class 2 device.
What It Is
The cardiac supply tray is a medical device designed for use in venous stent procedures. It provides necessary tools and components for clinicians to perform these interventions effectively.
Clinical Applications
Commonly used in procedures involving venous stents, the cardiac supply tray is integral in settings where precise and reliable access to cardiac structures is required.
Evidence Summary
The literature includes 11 studies, encompassing various study types such as retrospective analyses and randomized controlled trials, published between 2022 and 2025.
Reported Outcomes
Published studies report that the cardiac supply tray is effective in facilitating venous stent procedures, with outcomes focusing on procedural success and device reliability. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include potential leakage during procedures, as noted in studies involving similar devices. No specific adverse events directly linked to the cardiac supply tray are detailed in the provided evidence.
Evidence Limitations
The evidence base lacks detailed outcome metrics specific to the cardiac supply tray, and further research is needed to establish comprehensive safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for the cardiac supply tray?
The cardiac supply tray is indicated for use in venous stent procedures, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report procedural success and device reliability, though specific metrics are not detailed in the provided evidence.
What complications have been reported?
Safety data indicate potential leakage during procedures, but no specific adverse events related to the cardiac supply tray are detailed.
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.