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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-cleared and linked to two clinical studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway
510K
Number
K971608 ↗
Decision Date
July 21, 1997
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 510(k) pathway on July 21, 1997. 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 vascular access for procedures requiring embolization coils. It is intended for use by clinicians in interventional radiology and cardiology settings.
Clinical Applications
This device is commonly used in clinical scenarios involving the introduction of embolization coils, particularly in vascular interventions. It provides a stable and reliable means of accessing the vascular system.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov, though specific details on study types, participant numbers, and date ranges are not provided. Further research is needed to fully understand the device's clinical impact.
Reported Outcomes
Published studies report limited specific outcomes related to the Cordis Brite Tip Catheter Sheath Introducer System. The studies listed do not provide detailed efficacy findings, highlighting a gap in the available evidence.
Safety Profile
Reported complications include a lack of detailed safety data from the provided studies. The studies do not specify adverse events, indicating a need for more comprehensive safety evaluations.
Evidence Limitations
The current evidence is limited by the lack of detailed study outcomes and safety data. Further research is necessary to establish comprehensive efficacy and safety profiles for the Cordis Brite Tip Catheter Sheath Introducer System.
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, particularly for the introduction 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 clear outcomes.
What complications have been reported?
Safety data from the evidence is not detailed, highlighting a gap in the reporting of potential complications.
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.