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dib ultranav transseptal catheter system
Dib Ultranav Medical
Summary: The Dib Ultranav Transseptal Catheter System is a medical device used for transseptal access in cardiac procedures. It is primarily used by cardiologists and electrophysiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K213492 ↗
Decision Date
March 24, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Dib Ultranav Transseptal Catheter System was cleared through the FDA 510k pathway on March 24, 2022. Manufactured by Dib Ultranav Medical, it is classified as a Class 2 device.
What It Is
The Dib Ultranav Transseptal Catheter System is designed to facilitate transseptal access to the left atrium of the heart. This system is used during procedures such as atrial fibrillation ablation or left atrial appendage closure. It typically consists of a sheath and dilator that allow for precise and controlled puncture of the interatrial septum, providing a pathway for other catheters to reach the left side of the heart.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures that require access to the left atrium, such as pulmonary vein isolation or mitral valve repair. It is particularly useful in patients with atrial fibrillation or other arrhythmias that necessitate intervention on the left side of the heart. Cardiologists and electrophysiologists in hospital settings are the primary users.
Indications for Use
The FDA indicates this device for use in procedures requiring transseptal access to the left atrium. It is suitable for patients undergoing interventions like atrial fibrillation ablation or other left atrial procedures.
Practical Considerations
The Dib Ultranav system is typically available in various sizes to accommodate different patient anatomies. It is compatible with standard electrophysiology lab equipment. Clinicians should be trained in transseptal puncture techniques to ensure safe and effective use.
Frequently Asked Questions
What is the Dib Ultranav Transseptal Catheter System used for?
It is used for transseptal access to the left atrium during cardiac procedures such as atrial fibrillation ablation.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for procedures requiring transseptal access to the left atrium, such as atrial fibrillation ablation.
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.