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lumax guiding catheter
Cook
Summary: The Lumax Guiding Catheter is a medical device used in interventional cardiology procedures, particularly for guiding other instruments through the vascular system. It is primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K191163 ↗
Decision Date
December 12, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Lumax Guiding Catheter was cleared through the FDA 510k pathway on December 12, 2019. It is manufactured by Cook and classified as a Class 2 device under product code DQY.
What It Is
The Lumax Guiding Catheter is a flexible tube designed to facilitate the introduction of interventional devices into the vascular system. It is used to navigate through blood vessels to reach specific sites within the cardiovascular system. The catheter's design allows for precise control and positioning, making it an essential tool in procedures such as angioplasty and stent placement.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings. It is employed in procedures that require the delivery of therapeutic devices, such as stents or balloons, to specific vascular locations. The Lumax Guiding Catheter is particularly useful in complex cases where precise navigation through tortuous vessels is necessary, and is often used in adult and pediatric patients with congenital or acquired heart conditions.
Indications for Use
The FDA indications for the Lumax Guiding Catheter include its use in procedures requiring vascular access and guidance of other devices. It is suitable for patients needing interventions in the cardiovascular system, such as those with blocked or narrowed vessels.
Practical Considerations
The Lumax Guiding Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of interventional devices and requires careful handling to avoid vessel trauma. Clinicians should be familiar with its use in conjunction with fluoroscopic guidance.
Related Literature
The linked study investigated the use of a telescopic system, including guiding catheters, for transcatheter radiofrequency perforation and balloon valvotomy in infants with pulmonary atresia and intact ventricular septum. The study found that this approach could reduce fluoroscopy time and morbidity, offering a viable alternative to surgical interventions. However, the study's limitations include its focus on a specific patient population and the need for further research to confirm these findings.
Frequently Asked Questions
What is the Lumax Guiding Catheter used for?
It is used to guide other interventional devices through the vascular system during procedures like angioplasty and stent placement.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use the Lumax Guiding Catheter.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access and guidance of interventional devices within the cardiovascular system.
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.