📋 FDA Reference
Lumax Guiding Catheter
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 ?
510(k)
Number ?
K191163 ↗
Decision Date ?
December 12, 2019
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- For percutaneous introduction and guidance of other devices within the vascular system.
- For use during intravascular diagnostic or interventional procedures when catheter guidance is required.
Clinical Applications
- Providing a conduit for introducing interventional devices into the vascular system.
- Guiding compatible catheters, wires, balloons, stents, or other devices to a target vascular location when permitted by the device labeling.
- Supporting percutaneous cardiovascular and peripheral vascular procedures that require stable catheter access and device delivery.
Reported off-label uses
- Use as a support or access catheter in selected complex peripheral venous interventions may occur in clinical practice, but this should be evaluated against the product labeling and institutional policy.
- Use in procedures outside the labeled vascular applications may be considered by specialists only when clinically justified and with appropriate informed consent.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The available catheter sizes, lengths, curves, and lumen dimensions should be matched to the target vessel, access site, anatomy, and devices being delivered.
- Use fluoroscopic or other appropriate imaging guidance, and advance the catheter gently to reduce the risk of dissection, perforation, spasm, or other vessel injury.
- Confirm compatibility with guidewires, balloons, stents, thrombectomy systems, and other devices before use; device-specific labeling controls compatibility.
- MRI safety depends on the exact catheter configuration and labeling. Do not assume that the catheter is MR safe or MR conditional without checking the current manufacturer instructions for use.
- Contraindications, warnings, anticoagulation requirements, and maximum pressure or injection limits should be taken from the current Cook labeling. The catheter is intended for single-use procedures and should not be resterilized or reused.
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.
Procedures that use this device
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.