📋 FDA Reference
Cordis Brite Tip Sheath Introducer
Summary: The Cordis Brite Tip Sheath Introducer is a medical device used to facilitate the introduction of catheters and other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K954595 ↗
Decision Date ?
December 28, 1995
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Cordis Brite Tip Sheath Introducer was cleared through the FDA 510(k) pathway on December 28, 1995. It is manufactured by Cordis and classified as a Class 2 device.
What It Is
The Cordis Brite Tip Sheath Introducer is a vascular access device designed to provide a conduit for the insertion of catheters and other interventional tools into the vascular system. It features a tapered tip to facilitate smooth entry and minimize trauma to the vessel. The device is typically used in procedures requiring vascular access, such as angiography or the deployment of embolization coils.
FDA-Cleared Indications
- Facilitate the introduction of catheters into the vascular system.
- Provide vascular access for procedures requiring insertion of catheters or other compatible devices.
Clinical Applications
- Vascular access during diagnostic angiography.
- Access for catheter-based peripheral vascular interventions.
- Access for embolization procedures requiring delivery of embolic agents or coils.
- Access for interventional cardiology procedures requiring catheter placement.
Practical Considerations
- The sheath is available in multiple sizes; the selected size must match the catheter or device being used and the target vessel.
- Insertion is generally performed over a guidewire using fluoroscopic or other image guidance, with local anesthesia and sedation as clinically appropriate.
- Clinicians should confirm compatibility with the intended catheter, guidewire and interventional device before use.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization and contrast-related complications.
- MRI safety depends on the specific product configuration and whether the sheath remains in place; the current product labeling should be reviewed before MRI.
Procedures that use this device
Frequently Asked Questions
What is the Cordis Brite Tip Sheath Introducer used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters into the vascular system, particularly in procedures requiring vascular access.
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.