đź“‹ FDA Reference
pathbuilder transseptal guiding introducer
Shanghai Microport Ep Medtech
Summary: The Pathbuilder Transseptal Guiding Introducer is a medical device used to facilitate transseptal access in cardiac procedures. It is primarily used by cardiologists and electrophysiologists in catheter-based interventions.
FDA Clearance Information
Pathway
510K
Number
K212626 ↗
Decision Date
March 23, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pathbuilder Transseptal Guiding Introducer was cleared via the FDA 510(k) pathway on March 23, 2022. Manufactured by Shanghai Microport Ep Medtech, it is classified as a Class 2 device under product code DYB.
What It Is
The Pathbuilder Transseptal Guiding Introducer is a specialized catheter system designed to provide access to the left atrium of the heart through the septum. It is used in procedures requiring precise navigation and positioning within the heart, such as ablations or other electrophysiological interventions. The device typically includes a sheath and dilator system that allows for safe and controlled transseptal puncture.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures like atrial fibrillation ablation, where access to the left atrium is necessary. It is utilized by cardiologists and electrophysiologists in hospital settings, particularly in patients requiring complex catheter-based interventions. The device is essential for procedures that need precise guidance and stability during transseptal access.
Indications for Use
The FDA indications for the Pathbuilder Transseptal Guiding Introducer involve its use in facilitating transseptal access during cardiac procedures. It is intended for patients undergoing interventions that require entry into the left atrium, such as those with arrhythmias needing ablation.
Practical Considerations
Clinicians should be aware of the typical sizing options available for the Pathbuilder to ensure compatibility with other catheter systems. Proper technique in transseptal puncture is crucial to minimize risks, and familiarity with the device's handling characteristics can improve procedural outcomes.
Frequently Asked Questions
What is the Pathbuilder Transseptal Guiding Introducer used for?
It is used to facilitate transseptal access in cardiac procedures, particularly for interventions requiring entry into the left atrium.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in catheter-based cardiac interventions.
What are the FDA-cleared indications?
The device is indicated for facilitating transseptal access during cardiac procedures, especially those involving 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.