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envoy and vista brite tip
Cordis
Summary: The Envoy and Vista Brite Tip are venous stents used in interventional radiology and cardiology to treat venous obstructions. They are typically used by specialists in hospitals and outpatient settings.
FDA Clearance Information
Pathway
510K
Number
K000715 ↗
Decision Date
March 31, 2000
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Envoy and Vista Brite Tip, manufactured by Cordis, received FDA clearance through the 510(k) pathway on March 31, 2000. These devices are classified as Class 2 under product code DQY.
What It Is
The Envoy and Vista Brite Tip are medical devices designed as venous stents. They are used to support and maintain the patency of veins, particularly in cases where there is a risk of venous obstruction. These stents are typically made from materials that are compatible with the human body and are designed to be flexible yet sturdy enough to withstand the pressures within the venous system.
Clinical Applications
These stents are commonly used in procedures to treat conditions such as venous stenosis or occlusion. Interventional radiologists and cardiologists often deploy these stents in hospital catheterization labs or specialized outpatient centers. They are particularly useful in patients with chronic venous insufficiency or those who have undergone previous venous interventions.
Indications for Use
The FDA indications suggest that the Envoy and Vista Brite Tip are meant for patients experiencing venous blockages. These devices help restore normal blood flow in veins that have been narrowed or blocked due to various medical conditions.
Practical Considerations
The Envoy and Vista Brite Tip stents come in various sizes to accommodate different vein diameters. They are compatible with standard catheter systems and require careful handling during insertion to ensure proper placement and function.
Frequently Asked Questions
What is Envoy and Vista Brite Tip used for?
These devices are used to treat venous obstructions by maintaining open blood flow in the veins.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use these stents in their procedures.
What are the FDA-cleared indications?
The stents are indicated for use in patients with venous blockages to restore and maintain normal blood flow.
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.