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modification to cordis brite tip catheter sheath introducer system
Cordis
Summary: The modification to the Cordis Brite Tip Catheter Sheath Introducer System is a Class 2 medical device used primarily for embolization-coils. Key evidence includes studies on its use in peripheral arteries.
FDA Clearance Information
Pathway
510K
Number
K983023 ↗
Decision Date
October 1, 1998
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on October 1, 1998. It is manufactured by Cordis and classified as a Class 2 device under product code DYB.
What It Is
The modification to 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 involving embolization-coils.
Clinical Applications
This device is commonly used in interventional cardiology and radiology, particularly for procedures requiring the introduction of embolization-coils. It is suitable for both above and below the knee peripheral artery interventions.
Evidence Summary
The available literature includes three studies: one published in 1996 and two ongoing clinical trials. These studies focus on the device's application in peripheral artery interventions.
Reported Outcomes
Published studies report that the device is effective in facilitating directional coronary atherectomy and peripheral artery interventions. The 9 French guiding catheter was noted for its large lumen and compatibility with atherectomy catheters.
Safety Profile
Reported complications include potential ostial trauma and peripheral vascular complications due to the rigidity of the guiding catheters. No additional safety data is provided in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of comprehensive safety data. Further research is needed to assess long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for modification to Cordis Brite Tip Catheter Sheath Introducer System?
The device is indicated for use in procedures involving embolization-coils, particularly in peripheral artery interventions.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of directional coronary atherectomy and peripheral artery interventions.
What complications have been reported?
Safety data indicates potential for ostial trauma and peripheral vascular complications due to catheter rigidity.
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.