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cordis introducing catheter
Cordis
Summary: The Cordis Introducing Catheter is a device used for embolization procedures, particularly with embolization coils. Key evidence highlights its application in neuroendovascular treatments and tumor embolization.
FDA Clearance Information
Pathway
510K
Number
K945524 ↗
Decision Date
April 26, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Introducing Catheter was cleared by the FDA via the 510(k) pathway on April 26, 1995. It is manufactured by Cordis and classified as a Class 2 medical device.
What It Is
The Cordis Introducing Catheter is designed to facilitate the delivery of embolization coils in endovascular procedures. It is used in clinical settings for precise catheterization and embolization of targeted vessels.
Clinical Applications
Commonly used in procedures involving embolization of tumors and vascular malformations, the catheter is particularly useful in neuroendovascular treatments and other interventional radiology applications.
Evidence Summary
The available literature includes a mix of case reports and studies focusing on embolization techniques. The studies span from 2023 to 2025, highlighting various clinical applications and outcomes.
Reported Outcomes
Published studies report successful use of the Cordis Introducing Catheter in tumor embolization and neuroendovascular procedures. The device has been shown to facilitate effective embolization with minimal complications in reported cases.
Safety Profile
Reported complications include potential risks associated with catheterization, such as vessel injury or embolic events. However, the studies reviewed did not highlight significant adverse events directly linked to the catheter itself.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and safety profiles in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Cordis Introducing Catheter?
The catheter is indicated for use in embolization procedures, particularly in neuroendovascular treatments and tumor embolization.
What outcomes have been reported in clinical studies?
Studies have reported successful embolization outcomes with minimal complications, particularly in neuroendovascular and tumor embolization procedures.
What complications have been reported?
Safety data from evidence indicate potential risks such as vessel injury or embolic events, though significant adverse events directly linked to the catheter are not highlighted.
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.