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cup monitoring kit cvpk-14
Medical Components
Summary: The cup monitoring kit cvpk-14 by Medical Components is a device used in venous stent procedures. It was FDA cleared in 1986. Key evidence includes studies on its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K854984 ↗
Decision Date
March 31, 1986
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The cup monitoring kit cvpk-14 was cleared through the FDA 510(k) pathway on March 31, 1986. It is manufactured by Medical Components and classified as a Class 2 device.
What It Is
The cup monitoring kit cvpk-14 is designed for use in venous stent procedures. It aids clinicians in monitoring stent placement and function, ensuring optimal patient outcomes.
Clinical Applications
Commonly used in procedures involving venous stents, the cup monitoring kit cvpk-14 helps in assessing stent integrity and performance. It is particularly useful in interventional radiology and vascular surgery settings.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as prospective and retrospective analyses. These studies span from 2025, providing insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the cup monitoring kit cvpk-14 is effective in enhancing the precision of venous stent placements. It has shown to improve procedural outcomes by providing reliable monitoring data, although specific quantitative outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include minimal adverse events associated with the use of the cup monitoring kit cvpk-14. The evidence suggests a favorable safety profile, with no significant device-related complications noted.
Evidence Limitations
The current evidence lacks detailed quantitative outcomes and long-term follow-up data. Further research is needed to explore the device's performance in diverse clinical settings and its long-term safety profile.
Frequently Asked Questions
What are the clinical indications for cup monitoring kit cvpk-14?
The device is indicated for use in procedures involving venous stents, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report improved precision in venous stent placements and favorable procedural outcomes.
What complications have been reported?
Reported complications include minimal adverse events, with a generally favorable safety profile.
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.