đź“‹ FDA Reference
centercross ultra catheter
Roxwood Medical
Summary: The CenterCross Ultra Catheter is a medical device used in interventional cardiology for navigating complex vascular pathways. It is primarily used by cardiologists and interventional radiologists to facilitate the placement of stents in patients with stenotic lesions or chronic total occlusions.
FDA Clearance Information
Pathway
510K
Number
K152456 ↗
Decision Date
January 26, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CenterCross Ultra Catheter was cleared via the FDA 510(k) pathway on January 26, 2016. Manufactured by Roxwood Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The CenterCross Ultra Catheter is a specialized catheter designed to assist in the navigation and placement of stents in complex vascular procedures. It features a unique design that allows for enhanced control and precision when crossing stenotic lesions or chronic total occlusions. This device is particularly useful in cases where traditional catheters may struggle to navigate tortuous or highly occluded vessels.
Clinical Applications
The CenterCross Ultra Catheter is commonly used in interventional cardiology and radiology settings, particularly in procedures involving the placement of venous stents. It is suitable for patients with challenging vascular anatomy, such as those with chronic total occlusions or severe stenosis. The device is typically employed in catheterization labs by specialists trained in endovascular techniques.
Indications for Use
The FDA indications for the CenterCross Ultra 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, where enhanced catheter navigation is required.
Practical Considerations
The CenterCross Ultra Catheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and stent delivery systems. Clinicians should be familiar with the device's handling characteristics to optimize its use in complex vascular interventions.
Related Literature
The linked study is a registry evaluating the performance and safety of Roxwood Medical catheters, including the CenterCross Ultra, in patients with stenotic lesions or chronic total occlusions. While specific results and limitations are not detailed, such studies typically assess the device's efficacy in navigating difficult vascular pathways and its safety profile in real-world clinical settings.
Frequently Asked Questions
What is the CenterCross Ultra Catheter used for?
It is used to facilitate the navigation and placement of stents in patients with stenotic lesions or chronic total occlusions.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in patients with stenotic lesions or chronic total occlusions, aiding in complex vascular interventions.
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.