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modification to envoy and vista brite tip
Cordis
Summary: The modification to Envoy and Vista Brite Tip by Cordis is a Class 2 medical device used in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K021593 ↗
Decision Date
June 13, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on June 13, 2002. It is manufactured by Cordis and classified as a Class 2 device under product code DQY.
What It Is
This device is a modification of existing catheter systems, designed to facilitate the placement of stents in venous structures. It features enhancements that improve navigation through the vascular system and provide better support during stent deployment. The device is part of the Envoy and Vista Brite Tip family, known for their flexibility and radiopacity, which aid in precise placement.
Clinical Applications
The device is commonly used in procedures involving the placement of venous stents, particularly in cases of venous obstruction or insufficiency. Interventional radiologists and vascular surgeons use it in hospital settings, often in catheterization labs. It is suitable for adult patients who require venous stenting due to conditions like deep vein thrombosis or chronic venous insufficiency.
Indications for Use
The FDA indications suggest that this device is intended for use in patients who need venous stenting. It is particularly relevant for those with venous blockages or conditions that impair normal blood flow in veins.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and is compatible with standard stent delivery systems. Clinicians should be familiar with catheter navigation techniques and ensure proper sizing to minimize complications.
Frequently Asked Questions
What is modification to envoy and vista brite tip used for?
It is used for placing stents in venous structures to treat conditions like venous obstruction or insufficiency.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is cleared for use in venous stenting procedures, particularly for treating venous blockages or insufficiencies.
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.