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flexcath cross transseptal solution
Acutus Medical
Summary: The Flexcath Cross Transseptal Solution is a medical device used for transseptal access in cardiac procedures. It is primarily utilized by cardiologists and electrophysiologists during catheter-based interventions.
FDA Clearance Information
Pathway
510K
Number
K233691 ↗
Decision Date
December 17, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Flexcath Cross Transseptal Solution was cleared through the FDA 510(k) pathway on December 17, 2023. Manufactured by Acutus Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Flexcath Cross Transseptal Solution is designed to facilitate transseptal access to the left atrium during cardiac procedures. It consists of a sheath and dilator system that allows for precise and controlled puncture of the atrial septum. This device is crucial in procedures requiring left atrial access, such as catheter ablation for atrial fibrillation.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures like atrial fibrillation ablation, where access to the left atrium is necessary. It is typically employed by cardiologists and electrophysiologists in hospital settings. The Flexcath Cross is particularly useful for patients undergoing complex cardiac interventions that require precise transseptal puncture.
Indications for Use
The device is indicated for use in patients requiring transseptal access to the left atrium for cardiac procedures. It is suitable for conditions such as atrial fibrillation where catheter-based interventions are performed.
Practical Considerations
The Flexcath Cross is available in various sizes to accommodate different patient anatomies. It is compatible with standard electrophysiology catheters and requires familiarity with transseptal puncture techniques. Clinicians should ensure proper alignment and positioning to minimize complications.
Frequently Asked Questions
What is Flexcath Cross Transseptal Solution used for?
It is used for transseptal access to the left atrium during cardiac procedures like catheter ablation.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for transseptal access in cardiac procedures requiring left atrial entry.
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.