📊 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-cleared and linked to two clinical studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of vascular access for procedures requiring the introduction of embolization coils.
- Use by trained clinicians during endovascular vascular interventions, consistent with the device labeling.
Clinical Applications
- Providing access for endovascular embolization procedures using embolization coils.
- Supporting catheter or coil delivery during selected arterial embolization procedures.
- Providing a stable vascular access route during interventional radiology or cardiology procedures involving coil embolization.
Reported off-label uses
- Use as an access sheath during endovascular procedures that do not involve embolization coils may occur in practice, but this should be determined by the treating clinician and is not established by the stated FDA indication.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The appropriate sheath size and length depend on the access vessel, target anatomy, and outer diameter of the catheter or embolization system being used.
- Compatibility with guidewires, catheters, coils, and other accessories should be confirmed before the procedure.
- The system is typically inserted through percutaneous arterial or venous access using fluoroscopic or other appropriate imaging guidance.
- Potential access-site and vascular complications include bleeding, hematoma, infection, thrombosis, vessel injury, and embolic complications.
- MRI safety and conditional use depend on the specific system components and labeling; verify the current manufacturer instructions 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, 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.