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microcross catheter
Roxwood Medical
Summary: The MicroCross Catheter by Roxwood Medical is a Class 2 medical device used in vascular procedures to navigate through stenotic lesions or chronic total occlusions. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K143744 ↗
Decision Date
April 14, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The MicroCross Catheter was cleared through the FDA 510(k) pathway on April 14, 2015. Manufactured by Roxwood Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The MicroCross Catheter is a specialized medical device designed to assist in the navigation and treatment of vascular occlusions. It is used to facilitate the crossing of stenotic lesions or chronic total occlusions in blood vessels, particularly in the peripheral and coronary arteries. The catheter's design allows for enhanced maneuverability and support during complex interventional procedures.
Clinical Applications
The MicroCross Catheter is commonly used in interventional cardiology and radiology settings. It is particularly valuable in procedures involving the treatment of peripheral artery disease (PAD) and coronary artery disease (CAD), where navigating through blocked or narrowed vessels is necessary. Patients with chronic total occlusions or significant stenosis are typical candidates for procedures utilizing this catheter.
Indications for Use
The FDA-cleared indications for the MicroCross Catheter include its use in patients with stenotic lesions or chronic total occlusions. This means it is intended for individuals with significant narrowing or complete blockage of blood vessels, often seen in conditions like PAD or CAD.
Practical Considerations
The MicroCross Catheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and can be used in conjunction with other interventional tools. Clinicians should be familiar with catheterization techniques and vessel anatomy to optimize its use.
Related Literature
The linked registry study evaluated the performance and safety of Roxwood Medical catheters, including the MicroCross, in patients with stenotic lesions or chronic total occlusions. While specific results are not detailed, such studies typically assess device efficacy and safety outcomes. Limitations may include a lack of randomization and potential selection bias, common in registry studies.
Frequently Asked Questions
What is the MicroCross Catheter used for?
It is used to navigate and treat stenotic lesions or chronic total occlusions in blood vessels.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in patients with stenotic lesions or chronic total occlusions in blood vessels.
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.