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multicross support catheter
Roxwood Medical
Summary: The multicross support catheter by Roxwood Medical is a Class 2 medical device used in interventional cardiology for navigating through stenotic lesions or chronic total occlusions. It is primarily used by cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K121763 ↗
Decision Date
November 27, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The multicross support catheter was cleared through the FDA 510k pathway on November 27, 2012. Manufactured by Roxwood Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The multicross support catheter is a specialized tool used in interventional cardiology to facilitate the crossing of stenotic lesions or chronic total occlusions in blood vessels. It is designed to provide support and stability to guidewires and other interventional devices during complex procedures. The catheter's design allows for enhanced maneuverability and access in challenging vascular anatomy.
Clinical Applications
This device is commonly used in procedures involving the treatment of coronary artery disease, particularly in cases with complex stenotic lesions or chronic total occlusions. It is utilized in catheterization labs by interventional cardiologists and vascular surgeons. The multicross support catheter is especially beneficial in patients with difficult-to-treat vascular blockages, providing a means to deliver therapeutic devices to the site of occlusion.
Indications for Use
The FDA-cleared indications for the multicross support 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 traditional catheterization techniques may be insufficient.
Practical Considerations
The multicross support catheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and interventional devices. Clinicians should be familiar with the catheter's handling characteristics and ensure proper technique to maximize its effectiveness.
Related Literature
The linked registry study evaluated the performance and safety of Roxwood Medical catheters in patients with stenotic lesions or chronic total occlusions. Although specific details and findings are not available, such studies typically assess the device's success in crossing occlusions and its safety profile. Limitations may include the lack of a control group or long-term follow-up data.
Frequently Asked Questions
What is the multicross support catheter used for?
It is used to facilitate the crossing of 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 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, meaning narrowed or blocked 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.