đź“‹ FDA Reference
centercross catheter
Roxwood Medical
Summary: The CenterCross Catheter by Roxwood Medical is a Class 2 medical device used primarily in vascular procedures to assist in crossing stenotic lesions or chronic total occlusions. It is typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K140910 ↗
Decision Date
November 19, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CenterCross Catheter was cleared via the FDA 510(k) pathway on November 19, 2014. Manufactured by Roxwood Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The CenterCross Catheter is a specialized catheter designed to facilitate the crossing of stenotic lesions or chronic total occlusions in blood vessels. It features a unique design that aids in guiding wires and other devices through challenging vascular pathways. This device is particularly useful in complex interventional procedures where traditional catheters may struggle to navigate occluded or narrowed vessels.
Clinical Applications
The CenterCross Catheter is commonly used in interventional cardiology and vascular surgery settings. It is particularly valuable in procedures involving the treatment of chronic total occlusions (CTOs) and severe stenotic lesions in both coronary and peripheral arteries. Patients who benefit from this device typically have complex vascular conditions that require precise navigation and crossing of blockages.
Indications for Use
The FDA indications for the CenterCross Catheter include its use in patients with stenotic lesions or chronic total occlusions. This means it is intended for individuals with narrowed or completely blocked blood vessels, where it assists in facilitating the passage of guidewires and other interventional tools.
Practical Considerations
The CenterCross Catheter is available in various sizes to accommodate different vessel diameters and anatomical challenges. It is compatible with standard guidewires and interventional tools, making it a versatile option in the cath lab. Clinicians should be familiar with its deployment technique to maximize its effectiveness in complex cases.
Related Literature
The linked registry study evaluated the performance and safety of Roxwood Medical catheters, including the CenterCross, in patients with stenotic lesions or chronic total occlusions. While specific findings are not detailed, the study aimed to assess the device's effectiveness in real-world clinical settings. Limitations include the lack of an available abstract and detailed results, which restricts comprehensive analysis.
Frequently Asked Questions
What is the CenterCross Catheter used for?
It is used to assist in crossing stenotic lesions or chronic total occlusions in blood vessels during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use the CenterCross Catheter.
What are the FDA-cleared indications?
The device 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.