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 ?
510(k)
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.
FDA-Cleared Indications
- Use in electrophysiology procedures requiring catheter navigation, positioning, or access within the heart.
- Use to facilitate the delivery and placement of compatible diagnostic or therapeutic electrophysiology catheters.
Clinical Applications
- Catheter access and positioning during cardiac electrophysiology studies.
- Support for catheter-based treatment procedures for cardiac rhythm disorders when used with compatible electrophysiology devices.
- Navigation and exchange of compatible catheters during intracardiac procedures.
Practical Considerations
- Use only with compatible catheters and accessories specified in the device labeling.
- Select the appropriate system configuration and size for the intended cardiac anatomy and procedure.
- The procedure is typically performed through vascular access, commonly the femoral vein, with fluoroscopic and/or electroanatomic imaging guidance.
- Follow the manufacturer’s instructions for insertion, manipulation, flushing, and device exchange to reduce the risk of air embolism, thrombosis, vascular injury, or cardiac perforation.
- MRI safety and conditional-use conditions should be confirmed in the current manufacturer labeling; do not assume the system is MRI safe after implantation or use.
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.