đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitates transseptal access during cardiac catheterization procedures.
- Provides a pathway for catheter access from the right atrium to the left atrium through the interatrial septum.
Clinical Applications
- Establishing transseptal access for catheter-based procedures involving the left atrium.
- Supporting access during electrophysiology procedures when left-atrial catheter placement is required.
- Supporting access during structural or interventional cardiac procedures that require passage through the interatrial septum.
Practical Considerations
- Use requires a compatible transseptal sheath and puncture system; clinicians should confirm component compatibility and sizing before the procedure.
- The device is used under fluoroscopic and, when appropriate, intracardiac or transesophageal echocardiographic guidance.
- Transseptal access should be performed by clinicians trained in the technique because complications can include cardiac perforation, pericardial effusion, bleeding, air embolism and arrhythmia.
- The appropriate device size depends on the access system, catheter requirements and patient anatomy; users should follow the current manufacturer instructions for use.
- MRI safety and conditional-use information should be confirmed in the current labeling. Do not assume that the dilator or an assembled access system is MRI safe.
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.