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versacross connect transseptal dilator
Baylis Medical
Summary: The Versacross Connect Transseptal Dilator is a medical device used for transseptal access in cardiac procedures. It is typically used by cardiologists and electrophysiologists during interventions such as atrial fibrillation ablation.
FDA Clearance Information
Pathway
510K
Number
K220414 ↗
Decision Date
May 9, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Versacross Connect Transseptal Dilator was cleared via the FDA 510(k) pathway on May 9, 2022. Manufactured by Baylis Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Versacross Connect Transseptal Dilator is a specialized medical device designed to facilitate transseptal puncture and access to the left atrium of the heart. It is typically used in conjunction with a sheath and needle to create a passage through the interatrial septum, allowing for catheter-based interventions. This device is crucial for procedures that require precise access to the left atrium, such as electrophysiological studies and ablations.
Clinical Applications
This device is commonly used in cardiac electrophysiology and interventional cardiology. It is essential for procedures like atrial fibrillation ablation, where access to the left atrium is necessary. The device is used in hospital settings, particularly in catheterization labs, and is suitable for adult patients undergoing complex cardiac interventions.
Indications for Use
The FDA indications for the Versacross Connect Transseptal Dilator include its use in facilitating transseptal access during cardiac procedures. It is intended for patients requiring interventions that involve the left atrium, such as those with arrhythmias needing ablation therapy.
Practical Considerations
The Versacross Connect Transseptal Dilator is designed to be compatible with standard transseptal sheaths and needles. Clinicians should be familiar with transseptal puncture techniques and ensure appropriate sizing for patient anatomy. Proper handling and technique are crucial to minimize complications such as cardiac perforation.
Frequently Asked Questions
What is the Versacross Connect Transseptal Dilator used for?
It is used to facilitate transseptal access to the left atrium during cardiac procedures such as atrial fibrillation ablation.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in interventional cardiology and electrophysiology procedures.
What are the FDA-cleared indications?
The device is indicated for use in transseptal access during cardiac procedures requiring entry to the left atrium.
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.