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envoy and vista brite tip
Cordis
Summary: The Envoy and Vista Brite Tip are venous stents used primarily in interventional radiology and cardiology to support vessel patency. They are utilized by clinicians to treat venous obstructions.
FDA Clearance Information
Pathway 510K
Number K982632 ↗
Decision Date August 18, 1998
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Envoy and Vista Brite Tip were cleared via the FDA 510(k) pathway on August 18, 1998. Manufactured by Cordis, these devices are classified as Class II under product code DQY.
What It Is
The Envoy and Vista Brite Tip are specialized venous stents designed to maintain open blood vessels in the venous system. They are constructed to provide structural support to veins, preventing collapse and ensuring proper blood flow. These stents are typically delivered via catheter and expanded in place to fit the vessel's dimensions.
Clinical Applications
These stents are commonly used in procedures to treat venous obstructions, such as those caused by thrombosis or external compression. Interventional radiologists and cardiologists often deploy them in hospital settings, particularly in patients with chronic venous insufficiency or post-thrombotic syndrome. They are suitable for adult patients who require long-term venous patency.
Indications for Use
The FDA-cleared indications for the Envoy and Vista Brite Tip include maintaining vessel patency in patients with venous blockages. They are used in conditions where veins are narrowed or blocked, requiring mechanical support to restore adequate blood flow.
Practical Considerations
These stents come in various sizes to accommodate different vessel diameters and lengths. Compatibility with standard catheter delivery systems is essential, and clinicians should be familiar with the deployment technique to ensure proper placement and expansion within the vein.
Frequently Asked Questions
What is Envoy and Vista Brite Tip used for?
They are used to maintain open blood vessels in the venous system, particularly in cases of venous obstruction.
What specialties typically use this device?
Interventional radiology and cardiology specialists commonly use these stents.
What are the FDA-cleared indications?
They are indicated for maintaining vessel patency in patients with venous blockages.
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.