📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Provides transseptal access to the left atrium during cardiac catheter-based procedures.
Clinical Applications
- Establishing a catheter pathway from the right atrium to the left atrium.
- Supporting catheter-based procedures that require left atrial access.
- Providing access through the interatrial septum under appropriate imaging guidance.
Practical Considerations
- The system generally includes a transseptal sheath and dilator; available sizes and configurations should be confirmed in the current device labeling.
- Use requires clinicians trained in transseptal puncture and management of potential complications such as cardiac perforation, pericardial effusion, bleeding, air embolism and vascular injury.
- Transseptal access is typically performed in a cardiac catheterization or electrophysiology laboratory using fluoroscopy, often with echocardiographic guidance.
- MRI safety and conditions should be verified in the current manufacturer labeling; this record does not establish that the system is MR Safe or MR Conditional.
- Patient-specific contraindications, anticoagulation management, septal anatomy and the need for alternative access should be assessed before 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.