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centercross ultra lv catheter
Roxwood Medical
Summary: The CenterCross Ultra LV Catheter is a medical device used to facilitate the placement of guidewires in complex vascular procedures. It is primarily utilized by interventional cardiologists and radiologists in the treatment of venous stenosis and chronic total occlusions.
FDA Clearance Information
Pathway
510K
Number
K170403 ↗
Decision Date
March 7, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CenterCross Ultra LV Catheter was cleared through the FDA 510(k) pathway on March 7, 2017. It is manufactured by Roxwood Medical and classified as a Class 2 device under product code DQY.
What It Is
The CenterCross Ultra LV Catheter is a specialized catheter designed to aid in the navigation and placement of guidewires across stenotic lesions or chronic total occlusions in the vasculature. It features a unique design that allows for enhanced control and precision during complex interventions. This device is particularly useful in cases where traditional guidewire techniques are challenging.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology settings, particularly during procedures involving venous stents or the treatment of chronic total occlusions. It is suitable for use in patients with complex vascular anatomy or where previous attempts to cross lesions have been unsuccessful. The device is typically employed in hospital catheterization labs by specialists trained in endovascular techniques.
Indications for Use
The CenterCross Ultra LV Catheter is indicated for use in patients with stenotic lesions or chronic total occlusions, primarily in the venous system. It is designed to facilitate the crossing of challenging vascular blockages, making it suitable for patients with complex vascular conditions.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and is compatible with standard guidewires used in endovascular procedures. Clinicians should be familiar with its deployment technique, which may require specific training to optimize its use in complex cases.
Related Literature
The linked study is a registry evaluating the performance and safety of Roxwood Medical catheters in patients with stenotic lesions or chronic total occlusions. While specific results are not available, such studies typically assess the success rate of lesion crossing and any associated complications. Limitations may include a lack of randomized control and potential selection bias.
Frequently Asked Questions
What is the CenterCross Ultra LV Catheter used for?
It is used to facilitate the placement of guidewires across stenotic lesions or chronic total occlusions in the vasculature.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients with stenotic lesions or chronic total occlusions, aiding in the crossing of vascular blockages.
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.