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cordis brite tip catheter sheath introducer system
Cordis
Summary: The Cordis Brite Tip Catheter Sheath Introducer System is a medical device used primarily for vascular access in embolization procedures. It is FDA 510k cleared with linked evidence from two clinical studies.
FDA Clearance Information
Pathway
510K
Number
K984500 ↗
Decision Date
December 23, 1998
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Brite Tip Catheter Sheath Introducer System was cleared by the FDA via the 510k pathway on December 23, 1998. It is manufactured by Cordis and classified as a Class 2 device.
What It Is
The Cordis Brite Tip Catheter Sheath Introducer System is designed to facilitate the introduction of interventional devices into the vascular system. It is commonly used in procedures requiring vascular access, such as embolization.
Clinical Applications
This device is typically used in clinical scenarios involving embolization procedures, where precise vascular access is crucial. It is particularly relevant in cardiology and interventional radiology settings.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov. These studies focus on the safety and efficacy of related vascular access procedures, although specific outcomes and safety data are not detailed.
Reported Outcomes
Published studies report limited specific efficacy findings for the Cordis Brite Tip Catheter Sheath Introducer System due to the absence of detailed outcomes in the provided evidence.
Safety Profile
Reported complications include limited safety data from the provided studies, as specific adverse events or complications are not detailed in the evidence.
Evidence Limitations
The evidence for the Cordis Brite Tip Catheter Sheath Introducer System is limited by the lack of detailed outcomes and safety data in the available studies. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Cordis Brite Tip Catheter Sheath Introducer System?
The device is indicated for use in procedures requiring vascular access, such as embolization.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the provided evidence.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications 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.