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adroit guiding catheter
Cordis
Summary: The Adroit Guiding Catheter by Cordis is a device used primarily in venous-stent procedures. It is FDA 510k cleared with linked evidence from three PMCF studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway 510K
Number K143412 ↗
Decision Date January 14, 2015
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Adroit Guiding Catheter received FDA clearance through the 510k pathway on January 14, 2015. It is manufactured by Cordis and classified as a Class 2 medical device.
What It Is
The Adroit Guiding Catheter is designed to facilitate the placement of interventional devices within the vascular system. It is primarily used in procedures involving venous stents, providing support and guidance for other devices.
Clinical Applications
This catheter is commonly used in cardiology and peripheral vascular procedures, particularly where precise navigation and support are required for stent placement. It is utilized in both above and below the knee arterial interventions.
Evidence Summary
The available literature includes three PMCF studies registered on ClinicalTrials.gov. These studies focus on cardiology access procedures and peripheral arterial interventions, though specific participant numbers and outcomes are not detailed.
Reported Outcomes
Published studies report limited specific outcomes for the Adroit Guiding Catheter. The studies are ongoing, and detailed efficacy findings are not yet available in the provided evidence.
Safety Profile
Reported complications include general procedural risks associated with catheter use, though specific adverse events are not detailed in the available studies. Further data is needed to comprehensively assess safety.
Evidence Limitations
The current evidence lacks detailed outcome and safety data, as the studies are ongoing. Further research is needed to establish comprehensive efficacy and safety profiles for the Adroit Guiding Catheter.
Frequently Asked Questions
What are the clinical indications for Adroit Guiding Catheter?
The catheter is indicated for use in venous-stent procedures, particularly in cardiology and peripheral vascular interventions.
What outcomes have been reported in clinical studies?
Specific outcomes have not been detailed in the available studies, as they are ongoing.
What complications have been reported?
Reported complications include general procedural risks, but specific adverse events are not detailed in the current evidence.
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.