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coracross
Reflow Medical
Summary: The coracross is a venous stent used to treat venous obstructions. It is primarily used by interventional cardiologists and vascular specialists.
FDA Clearance Information
Pathway
510K
Number
K210188 ↗
Decision Date
May 28, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The coracross by Reflow Medical was cleared via the FDA 510k pathway on May 28, 2021. It is a Class 2 medical device under product code DQY.
What It Is
The coracross is a medical device designed to address venous obstructions by providing structural support to veins. It is typically used in procedures requiring the restoration of blood flow in obstructed venous pathways. The device is inserted into the vein where it expands to hold the vessel open, ensuring adequate blood circulation.
Clinical Applications
The coracross is commonly used in interventional cardiology and vascular surgery settings. It is particularly useful in treating patients with chronic venous insufficiency or those who have experienced venous thrombosis. The device is suitable for use in hospitals and specialized clinics where minimally invasive procedures are performed.
Indications for Use
The FDA-cleared indications for the coracross involve its use in patients with venous obstructions. It is intended for individuals who require intervention to restore proper blood flow in their veins.
Practical Considerations
The coracross comes in various sizes to accommodate different vein diameters. It is compatible with standard catheter delivery systems, and clinicians should ensure proper sizing and placement techniques to maximize efficacy and minimize complications.
Related Literature
The linked study evaluated the use of CORA catheters for crossing coronary chronic total occlusions. Although specific details and results are not available, such studies typically assess the device's effectiveness in navigating and treating blocked coronary arteries. Limitations may include a small sample size or lack of long-term follow-up data.
Frequently Asked Questions
What is coracross used for?
The coracross is used to treat venous obstructions by providing structural support to veins, ensuring proper blood flow.
What specialties typically use this device?
Interventional cardiologists and vascular specialists typically use the coracross.
What are the FDA-cleared indications?
The device is indicated for use in patients with venous obstructions requiring intervention to restore 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.