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Acumen Insight Endocardial Visualization System
Acumen Medical
Summary: The Acumen Insight Endocardial Visualization System is a medical device used for visualizing the interior of the heart. It is primarily used by cardiologists in procedures involving venous stents.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K070051 ↗
Decision Date ?
April 6, 2007
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Acumen Insight Endocardial Visualization System was cleared through the FDA 510(k) pathway on April 6, 2007. It is manufactured by Acumen Medical and classified as a Class 2 device under product code DQY.
What It Is
The Acumen Insight Endocardial Visualization System is designed to provide real-time imaging of the heart's interior structures. It utilizes advanced imaging technology to assist clinicians in visualizing the endocardial surface, which is crucial during procedures involving the placement of venous stents. This system enhances the accuracy and safety of such interventions by offering detailed visualization.
FDA-Cleared Indications
- Used to visualize the endocardial surface during cardiovascular procedures.
- Used as a percutaneous catheter-based visualization device under FDA product code DQY.
Clinical Applications
- Intravascular visualization during selected cardiovascular catheterization procedures.
- Real-time assessment of intracardiac or endocardial anatomy when direct visualization is clinically needed.
- Use in a cardiac catheterization laboratory with compatible imaging and catheter equipment.
Practical Considerations
- The supplied FDA summary does not specify catheter sizes, access routes, imaging-console compatibility, or a dedicated venous-stent indication; clinicians should consult the current labeling and instructions for use.
- Use requires appropriate percutaneous vascular access, imaging guidance, and operator training.
- Confirm compatibility with the catheterization laboratory system and other devices used during the procedure.
- MRI safety and conditional use cannot be determined from the provided FDA record; verify the device's current labeling before MRI.
- Contraindications, anticoagulation requirements, handling instructions, and maximum indwelling time should be taken from the current manufacturer labeling.
Frequently Asked Questions
What is the Acumen Insight Endocardial Visualization System used for?
It is used for visualizing the interior of the heart, particularly during procedures involving venous stents.
What specialties typically use this device?
This device is primarily used by interventional cardiologists in cardiac catheterization labs.
What are the FDA-cleared indications?
The device is indicated for visualizing the endocardial surface during procedures that require detailed imaging of the heart, especially for venous stent placement.
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.