đź“‹ FDA Reference
acqguide flex with acqcross qx acqguide mini with acqcross qx
Acutus Medical
Summary: The acqguide flex with acqcross qx is a medical device used in interventional cardiology and electrophysiology procedures. It is primarily utilized by cardiologists and electrophysiologists for precise catheter navigation and placement.
FDA Clearance Information
Pathway
510K
Number
K193509 ↗
Decision Date
January 17, 2020
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The acqguide flex with acqcross qx, manufactured by Acutus Medical, received FDA clearance through the 510(k) pathway on January 17, 2020. It is classified as a Class 2 device under product code DYB.
What It Is
The acqguide flex with acqcross qx is a specialized catheter system designed to facilitate the navigation and placement of other medical devices within the heart. It is particularly useful in procedures requiring precise control and positioning, such as catheter ablation for arrhythmias. The device integrates features that enhance maneuverability and stability, making it a valuable tool in complex cardiac interventions.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures like atrial fibrillation ablation, where precise catheter placement is crucial. It is often employed in hospitals and specialized cardiac centers, primarily by cardiologists and electrophysiologists. The acqguide flex with acqcross qx is suitable for adult patients undergoing interventional cardiac procedures.
Indications for Use
The device is indicated for use in cardiac procedures that require catheter navigation and placement, such as those targeting arrhythmias. It is designed to assist in the delivery of therapeutic interventions within the heart.
Practical Considerations
Clinicians should consider the compatibility of the acqguide flex with acqcross qx with other devices used in the procedure. It is important to follow recommended techniques for optimal performance, and to be aware of the device's sizing to ensure proper fit and function during interventions.
Frequently Asked Questions
What is acqguide flex with acqcross qx used for?
It is used for precise catheter navigation and placement in cardiac procedures, particularly in electrophysiology.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in interventional cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for use in cardiac procedures requiring catheter navigation and placement, such as arrhythmia treatments.
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.