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cordis brite tip envoy guiding catheter
Cordis
Summary: The Cordis Brite Tip Envoy Guiding Catheter is a medical device used to facilitate the introduction of interventional devices into the vascular system. It is commonly used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K952185 ↗
Decision Date
August 2, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cordis Brite Tip Envoy Guiding Catheter was cleared through the FDA 510(k) pathway on August 2, 1995. Manufactured by Cordis, it is classified as a Class 2 device under the product code DQY.
What It Is
The Cordis Brite Tip Envoy Guiding Catheter is a flexible tube designed to provide a conduit for the introduction of various interventional devices into the vascular system. Its design allows for precise navigation within the vasculature, facilitating procedures such as angioplasty or stent placement. The catheter's construction typically includes a soft tip to minimize trauma to the vessel walls.
Clinical Applications
This guiding catheter is primarily used in interventional cardiology and radiology for procedures involving the coronary and peripheral arteries. It is commonly employed in settings such as cardiac catheterization labs and interventional radiology suites. The device is suitable for adult patients requiring vascular interventions, particularly those with complex vascular anatomies.
Indications for Use
The FDA indications for the Cordis Brite Tip Envoy Guiding Catheter include its use in procedures that require the introduction of interventional devices into the vascular system. It is suitable for patients undergoing diagnostic or therapeutic vascular procedures.
Practical Considerations
The Cordis Brite Tip Envoy Guiding Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of interventional devices, and clinicians should be familiar with its handling characteristics to optimize procedural outcomes.
Frequently Asked Questions
What is the Cordis Brite Tip Envoy Guiding Catheter used for?
It is used to facilitate the introduction of interventional devices into the vascular system during procedures such as angioplasty or stent placement.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in cardiac catheterization labs and interventional radiology suites.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of interventional devices into the vascular system, suitable for diagnostic or therapeutic vascular interventions.
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.