đź“‹ FDA Reference
linebacker tm transseptal introducer 53cm 62cm 72cm
Ep Dynamics
Summary: The Linebacker TM Transseptal Introducer is a medical device used for transseptal access in cardiac procedures. It is primarily used by cardiologists and electrophysiologists to facilitate catheterization in procedures like ablation.
FDA Clearance Information
Pathway
510K
Number
K111603 ↗
Decision Date
August 23, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Linebacker TM Transseptal Introducer, manufactured by Ep Dynamics, was cleared via the FDA 510(k) pathway on August 23, 2012. It is classified as a Class 2 device under product code DYB.
What It Is
The Linebacker TM Transseptal Introducer is a specialized catheter introducer designed to facilitate transseptal access to the left atrium of the heart. It is available in lengths of 53cm, 62cm, and 72cm, allowing for flexibility in various patient anatomies. The device aids in the precise placement of catheters during complex cardiac procedures, ensuring safe and effective access across the atrial septum.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as atrial fibrillation ablation, where access to the left atrium is required. It is utilized by cardiologists and electrophysiologists in hospital settings, particularly in patients undergoing complex arrhythmia management. The introducer is essential for procedures that require precise catheter manipulation and positioning.
Indications for Use
The FDA-cleared indications for the Linebacker TM Transseptal Introducer involve its use in procedures requiring transseptal access to the heart, particularly for interventions in the left atrium. It is indicated for patients undergoing cardiac procedures where such access is necessary.
Practical Considerations
When using the Linebacker TM Transseptal Introducer, clinicians should consider the appropriate length based on patient anatomy and procedural requirements. Compatibility with existing catheter systems is crucial, and practitioners should be familiar with transseptal puncture techniques to ensure safe use.
Frequently Asked Questions
What is the Linebacker TM Transseptal Introducer used for?
It is used for transseptal access to the left atrium during cardiac procedures such as ablation.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in electrophysiology labs and hospital settings.
What are the FDA-cleared indications?
It is indicated for procedures requiring transseptal access to the heart, particularly for interventions in 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.