📊 Evidence-Based Reference
Cordis Brite Tip Catheter Sheath Introducer System
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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for the introduction of catheters and other compatible interventional devices.
- Use during diagnostic and therapeutic vascular procedures requiring percutaneous access.
Clinical Applications
- Obtaining vascular access for embolization procedures.
- Providing an access route for catheters used in interventional radiology.
- Introducing compatible devices into peripheral or central blood vessels during image-guided procedures.
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.
Practical Considerations
- The sheath size, length, dilator, and guidewire must match the intended access vessel and the outside diameter of the catheter or device being introduced.
- Access may be obtained through the femoral, radial, jugular, or another appropriate vessel depending on the procedure and anatomy.
- The system is generally placed using needle, guidewire, and fluoroscopic or ultrasound guidance, with local anesthesia and optional moderate sedation.
- Device compatibility, maximum pressure ratings, and any radiopaque-marker or tip characteristics should be confirmed in the current manufacturer labeling before use.
- MRI safety depends on the specific system configuration and whether the device remains in the patient; the current product labeling should be checked before MRI.
Procedures that use this device
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.