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cordis envoy vista brite tip guiding catheters
Cordis
Summary: The Cordis Envoy Vista Brite Tip Guiding Catheters are used in vascular procedures to guide other devices into the vasculature. Interventional cardiologists and radiologists commonly use them.
FDA Clearance Information
Pathway
510K
Number
K962362 ↗
Decision Date
August 8, 1996
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cordis Envoy Vista Brite Tip Guiding Catheters were cleared through the FDA 510(k) pathway on August 8, 1996, by Cordis. It is a Class 2 medical device.
What It Is
The Cordis Envoy Vista Brite Tip Guiding Catheters are specialized catheters designed to provide support and guidance for other interventional devices during vascular procedures. They feature a radiopaque tip for enhanced visibility under fluoroscopy, aiding in precise navigation through the vasculature. These catheters are crucial in facilitating the delivery of stents, balloons, and other therapeutic devices to target sites within the vascular system.
Clinical Applications
These guiding catheters are primarily used in interventional cardiology and radiology. They are essential in procedures such as angioplasty and stent placement, where precise navigation and stability are required. They are used in settings like cardiac catheterization labs and interventional radiology suites, often for patients with coronary artery disease or other vascular conditions.
Indications for Use
The FDA-cleared indications for these catheters involve their use in guiding other devices within the vascular system. They are suitable for patients requiring interventions like stent placement or balloon angioplasty, particularly in the coronary arteries.
Practical Considerations
The Cordis Envoy Vista Brite Tip Guiding Catheters come in various sizes to accommodate different vessel diameters and procedural needs. They are compatible with a range of interventional devices, and clinicians should ensure appropriate sizing and compatibility with other tools used during procedures.
Frequently Asked Questions
What is Cordis Envoy Vista Brite Tip Guiding Catheters used for?
They are used to guide and support other interventional devices during vascular procedures, such as stent placement or angioplasty.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use these guiding catheters in vascular procedures.
What are the FDA-cleared indications?
The catheters are indicated for use in guiding other devices within the vascular system, particularly during coronary 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.