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xo cross coronary support catheter
Transit Scientific
Summary: The XO Cross Coronary Support Catheter is a medical device used in interventional cardiology to support the placement of stents in coronary arteries. It is typically used by cardiologists during procedures to treat coronary artery disease.
FDA Clearance Information
Pathway
510K
Number
K214107 ↗
Decision Date
April 11, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The XO Cross Coronary Support Catheter received FDA clearance through the 510(k) pathway on April 11, 2022. Manufactured by Transit Scientific, it is classified as a Class 2 device under product code DQY.
What It Is
The XO Cross Coronary Support Catheter is a specialized catheter designed to facilitate the delivery and placement of stents in coronary arteries. It provides support and stability during interventional procedures, allowing for precise navigation through the vascular system. The catheter's design helps in crossing complex lesions and navigating tortuous anatomy, which is crucial in treating coronary artery disease.
Clinical Applications
This catheter is commonly used in interventional cardiology, particularly during percutaneous coronary interventions (PCI) to treat patients with coronary artery disease. It is utilized in hospital settings, often in catheterization labs, and is essential for procedures involving the placement of stents in narrowed or blocked coronary arteries. The device is suitable for adult patients who require coronary revascularization.
Indications for Use
The XO Cross Coronary Support Catheter is indicated for use in patients with coronary artery disease who require stent placement to restore blood flow. It is designed to assist in navigating and crossing challenging lesions in the coronary arteries.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and stents used in coronary interventions. Clinicians should be familiar with catheter manipulation techniques to optimize its performance during procedures.
Frequently Asked Questions
What is XO Cross Coronary Support Catheter used for?
It is used to support the placement of stents in coronary arteries during interventional cardiology procedures.
What specialties typically use this device?
Interventional cardiologists primarily use this device during percutaneous coronary interventions.
What are the FDA-cleared indications?
The device is indicated for use in patients with coronary artery disease requiring stent placement to improve blood flow.
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.