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tsi transseptal introducer
Pressure Products Medical Device Manufacturing
Summary: The TSI Transseptal Introducer is a medical device used for transseptal access to the left atrium, primarily by cardiologists during procedures such as catheter ablations. It is designed to facilitate safe and effective access across the atrial septum.
FDA Clearance Information
Pathway 510K
Number K181031 ↗
Decision Date October 26, 2018
Product Code DYB
Device Class Class 2
Evidence 0 studies
The TSI Transseptal Introducer was cleared through the FDA 510(k) pathway on October 26, 2018. Manufactured by Pressure Products Medical Device Manufacturing, it is classified as a Class 2 device under product code DYB.
What It Is
The TSI Transseptal Introducer is a specialized catheter system designed to provide access to the left atrium of the heart through the interatrial septum. It typically consists of a sheath and dilator that allows for the passage of other devices, such as catheters, into the left atrium. This device is crucial in procedures requiring precise transseptal puncture, such as electrophysiology studies and catheter ablations.
Clinical Applications
The TSI Transseptal Introducer is commonly used in electrophysiology labs during procedures like atrial fibrillation ablations, where access to the left atrium is necessary. Cardiologists and electrophysiologists in hospital settings frequently use this device. It is particularly useful for patients undergoing complex arrhythmia management or structural heart interventions.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in patients requiring transseptal access to the left atrium, often for procedures involving the treatment of arrhythmias or other cardiac interventions. It is suitable for patients where traditional access routes are inadequate.
Practical Considerations
Clinicians should be aware of the various sizes available to accommodate different patient anatomies and procedural needs. Compatibility with other cardiac devices, such as catheters and guidewires, is essential. Proper technique in transseptal puncture is critical to avoid complications.
Frequently Asked Questions
What is TSI Transseptal Introducer used for?
It is used for providing transseptal access to the left atrium during cardiac procedures like catheter ablations.
What specialties typically use this device?
Cardiology and electrophysiology specialties typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring transseptal access to the left atrium, often for arrhythmia treatments.
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.