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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. It is FDA 510k cleared and linked to two clinical studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway
510K
Number
K974448 ↗
Decision Date
February 6, 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 February 6, 1998. It is manufactured by Cordis and classified as a Class 2 device under product code DYB.
What It Is
The Cordis Brite Tip Catheter Sheath Introducer System is designed to facilitate the introduction of catheters into the vascular system. It is primarily used in procedures requiring vascular access, such as embolization.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures that require reliable vascular access. It is particularly useful in scenarios involving the placement of embolization coils.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov. However, specific details regarding study design, sample size, and outcomes are not provided in the current evidence summary.
Reported Outcomes
Published studies report limited data on the efficacy of the Cordis Brite Tip Catheter Sheath Introducer System. Specific outcomes from the linked studies are not detailed, indicating a need for further research to establish comprehensive efficacy data.
Safety Profile
Reported complications include limited information from the available studies. The current evidence does not provide specific safety data, highlighting a gap in the literature regarding adverse events.
Evidence Limitations
The evidence for the Cordis Brite Tip Catheter Sheath Introducer System is limited, with a lack of detailed outcomes and safety data from the available studies. Further research is needed to fill these gaps and provide a more comprehensive understanding of the device's clinical performance.
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 the placement of embolization coils.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are not detailed, indicating a need for further research to establish comprehensive efficacy data.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications detailed in the current studies.
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.