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adroit guiding catheter
Cordis Corp., A Johnson & Johnson
Summary: The Adroit Guiding Catheter by Cordis Corp. is used primarily in venous-stent procedures. It is FDA 510k cleared, with linked studies focusing on cardiology and peripheral artery access.
FDA Clearance Information
Pathway
510K
Number
K131225 ↗
Decision Date
May 29, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Adroit Guiding Catheter received FDA clearance via the 510k pathway on May 29, 2013. It is manufactured by Cordis Corp., a Johnson & Johnson company, and is classified as a Class 2 device.
What It Is
The Adroit Guiding Catheter is a medical device designed to facilitate the delivery of interventional devices in venous-stent procedures. It is intended for use in accessing and navigating vascular pathways.
Clinical Applications
Commonly used in cardiology and peripheral vascular interventions, the Adroit Guiding Catheter assists in the placement of stents and other devices within the venous system. It is particularly useful in complex vascular access scenarios.
Evidence Summary
The available literature includes three post-market clinical follow-up (PMCF) studies focusing on cardiology and peripheral artery procedures. These studies are registered on ClinicalTrials.gov but lack detailed outcomes and safety data.
Reported Outcomes
Published studies report limited data on the efficacy of the Adroit Guiding Catheter. The studies are ongoing, and specific outcomes have not been detailed in the available abstracts.
Safety Profile
Reported complications include limited safety data as the studies are still in progress. No specific adverse events have been detailed in the provided evidence.
Evidence Limitations
The current evidence base is limited by the lack of detailed outcomes and safety data from the ongoing studies. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Adroit Guiding Catheter?
The Adroit Guiding 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 evidence, as the studies are ongoing.
What complications have been reported?
Safety data is limited, with no specific complications 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.