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proxis flow-control device models eps 101 ic 101
Velocimed
Summary: The Proxis Flow-Control Device is used in interventional cardiology to manage blood flow during procedures involving venous stents. It is primarily utilized by cardiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K023548 ↗
Decision Date
August 4, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Proxis Flow-Control Device, manufactured by Velocimed, received FDA clearance through the 510(k) pathway on August 4, 2003. It is classified as a Class 2 medical device.
What It Is
The Proxis Flow-Control Device is designed to control blood flow during interventional procedures, particularly when deploying venous stents. It acts as a temporary occlusion device, allowing for better visualization and precision during stent placement. This device is particularly useful in maintaining a stable field during complex interventions.
Clinical Applications
Commonly used in interventional cardiology, the Proxis Flow-Control Device is employed during procedures that require precise control of blood flow, such as the placement of venous stents in patients with venous insufficiency or other vascular conditions. It is typically used in hospital catheterization labs by interventional cardiologists.
Indications for Use
The device is indicated for use in patients undergoing procedures that involve venous stenting, particularly where temporary control of blood flow is necessary to ensure accurate stent deployment and placement.
Practical Considerations
The Proxis Flow-Control Device is available in various sizes to accommodate different vessel diameters. It is compatible with standard catheterization lab equipment and requires familiarity with interventional techniques for optimal use.
Frequently Asked Questions
What is the Proxis Flow-Control Device used for?
It is used to control blood flow during procedures involving venous stents, aiding in precise stent placement.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting with temporary blood flow control.
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.