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Volcano
Summary: The Preview Forward-Looking IVUS Catheter by Volcano is an intravascular ultrasound device used for imaging within blood vessels, primarily in venous stent procedures. It is typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K122826 ↗
Decision Date
April 24, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 24, 2013. Manufactured by Volcano, it is classified as a Class 2 medical device under product code DQY.
What It Is
The Preview Forward-Looking IVUS Catheter is an intravascular ultrasound catheter designed to provide real-time imaging of the interior of blood vessels. It works by emitting ultrasound waves and capturing the reflected signals to create detailed images of the vessel walls and any stents present. This technology aids clinicians in assessing the placement and condition of venous stents, ensuring optimal patient outcomes.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings for procedures involving venous stents. It is particularly useful in evaluating stent deployment and monitoring for complications such as restenosis. The catheter is used in hospitals and specialized vascular centers, catering to patients with conditions requiring stent placement in venous systems.
Indications for Use
The FDA-cleared indications for this device involve its use in imaging and assessing venous stents. It is intended for patients who have undergone stent placement in their veins, helping clinicians ensure proper stent function and detect any issues early.
Practical Considerations
The catheter is compatible with standard intravascular ultrasound systems and is available in sizes suitable for various vessel diameters. Clinicians should be familiar with ultrasound imaging techniques and ensure proper calibration of the system for accurate results.
Frequently Asked Questions
What is the Preview Forward-Looking IVUS Catheter used for?
It is used for imaging and assessing the interior of blood vessels, particularly in procedures involving venous stents.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular imaging and stent assessment.
What are the FDA-cleared indications?
The device is indicated for use in imaging and assessing venous stents to ensure proper placement and function.
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.