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7f acumen coronary sinus visualization system model csvs-7-67
Acumen Medical
Summary: The 7f Acumen Coronary Sinus Visualization System is a medical device used for visualizing the coronary sinus during cardiac procedures. It is primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway 510K
Number K062084 ↗
Decision Date August 18, 2006
Product Code DQY
Device Class Class 2
Evidence 0 studies
The device was cleared through the FDA 510(k) pathway on August 18, 2006. It is manufactured by Acumen Medical and classified as a Class 2 device under product code DQY.
What It Is
The 7f Acumen Coronary Sinus Visualization System is designed to aid in the visualization of the coronary sinus, a large vein that collects blood from the heart muscle. The system enhances the ability to navigate and place devices within the coronary sinus, which is crucial during procedures such as cardiac resynchronization therapy. The device typically includes a catheter and imaging components that provide real-time visualization.
Clinical Applications
This device is commonly used in cardiac procedures that require access to the coronary sinus, such as the placement of pacemaker leads or venous stents. It is particularly useful in electrophysiology labs and cardiac catheterization suites. The device is used by cardiologists and interventional radiologists, especially in patients undergoing treatment for heart failure or arrhythmias.
Indications for Use
The device is indicated for use in visualizing the coronary sinus to facilitate the placement of devices like pacemaker leads. It is particularly beneficial for patients requiring cardiac resynchronization therapy or other interventions involving the coronary venous system.
Practical Considerations
The system is compatible with standard catheterization lab equipment and typically involves a 7 French catheter size. Clinicians should be familiar with catheter navigation techniques and the use of imaging systems for optimal results. Proper training in the use of the visualization system is recommended to ensure accurate placement and reduce procedural risks.
Frequently Asked Questions
What is the 7f Acumen Coronary Sinus Visualization System used for?
It is used for visualizing the coronary sinus during cardiac procedures to aid in the placement of devices like pacemaker leads.
What specialties typically use this device?
Cardiologists and interventional radiologists primarily use this device in cardiac catheterization and electrophysiology labs.
What are the FDA-cleared indications?
The device is cleared for visualizing the coronary sinus to assist in placing devices such as pacemaker leads, particularly in cardiac resynchronization therapy.
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.