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airbloc transseptal introducer 53 cm model fa001 airblock transseptal introducer 72 cm model fa002
Ep Dynamics
Summary: The Airbloc Transseptal Introducer 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
K090867 ↗
Decision Date
July 30, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Airbloc Transseptal Introducer, manufactured by Ep Dynamics, was cleared through the FDA 510k pathway on July 30, 2009. It is classified as a Class 2 device under product code DYB.
What It Is
The Airbloc Transseptal Introducer is a specialized catheter designed to facilitate transseptal access to the left atrium of the heart. It is available in two models, 53 cm and 72 cm, allowing for flexibility based on patient anatomy. The device is used to guide other instruments, such as catheters, into the left side of the heart for diagnostic or therapeutic procedures, ensuring safe and precise access.
Clinical Applications
This device is commonly used in procedures such as atrial fibrillation ablation, mitral valve repair, and other interventions requiring access to the left atrium. It is typically used in hospital settings, particularly in cardiac catheterization labs, by interventional cardiologists and electrophysiologists. The introducer is suitable for adult patients undergoing complex cardiac procedures.
Indications for Use
The Airbloc Transseptal Introducer is indicated for use in patients requiring transseptal access to the left atrium. This includes conditions like atrial fibrillation where catheter-based interventions are necessary.
Practical Considerations
The device comes in two lengths, 53 cm and 72 cm, to accommodate different patient anatomies. It is compatible with standard transseptal needles and catheters. Clinicians should be familiar with transseptal puncture techniques and ensure proper imaging guidance during the procedure.
Frequently Asked Questions
What is the Airbloc Transseptal Introducer 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?
Interventional cardiologists and electrophysiologists typically use this device in cardiac catheterization labs.
What are the FDA-cleared indications?
The device is indicated for transseptal access in procedures requiring entry to the left atrium, such as in atrial fibrillation treatment.
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.