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centercross ultra catheter
Roxwood Medical
Summary: The CenterCross Ultra Catheter is a medical device used by interventional cardiologists to facilitate the placement of stents in patients with venous stenosis or chronic total occlusions. It is designed to aid in navigating complex vascular pathways.
FDA Clearance Information
Pathway
510K
Number
K160681 ↗
Decision Date
June 17, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CenterCross Ultra Catheter was cleared through the FDA 510(k) pathway on June 17, 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 placement of stents within venous systems. It features a unique design that allows it to cross complex lesions and chronic total occlusions in the vasculature. The catheter's structure provides stability and support, facilitating the delivery of therapeutic devices such as stents to the target site.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery, particularly in procedures involving the treatment of venous stenosis or chronic total occlusions. It is utilized in hospital settings, often in catheterization labs, where precise navigation through challenging vascular pathways is required. The primary patient population includes those with significant venous blockages that require stenting.
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 narrowed or blocked veins that need intervention to restore proper blood flow.
Practical Considerations
The catheter is typically available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and stent delivery systems. Clinicians should be familiar with its handling and deployment techniques to maximize its effectiveness in complex vascular procedures.
Related Literature
The linked study was a registry evaluating the performance and safety of Roxwood Medical catheters in patients with stenotic lesions or chronic total occlusions. Although specific findings are not detailed, such studies generally assess the success rate of catheter navigation and stent placement, as well as any complications. Limitations include the lack of an available abstract and specific data, which restricts the detailed understanding of outcomes.
Frequently Asked Questions
What is the CenterCross Ultra Catheter used for?
It is used to assist in the placement of stents in patients with venous stenosis or chronic total occlusions.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons 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 the venous 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.