📋 FDA Reference
Coracross
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 ?
510(k)
Number ?
K210188 ↗
Decision Date ?
May 28, 2021
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous treatment of venous obstruction, consistent with the FDA product classification for a percutaneous catheter used in vascular procedures.
Clinical Applications
- Endovascular treatment of an obstructed vein.
- Use during minimally invasive venous procedures intended to restore blood flow.
- Treatment of selected venous lesions under catheter-based imaging guidance.
Practical Considerations
- The available record does not provide the device's specific approved dimensions, length range, delivery-system requirements, or deployment details; clinicians should consult the current FDA-cleared labeling and instructions for use.
- Device selection should be based on the target vein's anatomy, lesion characteristics, and required treatment length.
- Placement is typically performed through venous access with fluoroscopic or other appropriate imaging guidance.
- The record does not establish MRI safety. MRI conditions should be confirmed in the current labeling before scanning a patient with the device in place.
- Contraindications, anticoagulation requirements, and handling precautions should be taken from the manufacturer's current instructions for use.
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.
Procedures that use this device
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.