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nmt medical transseptal sheath set models tss-10-hsc tss-11-hsc tss12-hsc
Nmt Medical
Summary: The NMT Medical Transseptal Sheath Set is a device used in cardiac procedures to access the left atrium via the interatrial septum. It is primarily used by cardiologists in interventional settings.
FDA Clearance Information
Pathway
510K
Number
K034025 ↗
Decision Date
March 26, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The NMT Medical Transseptal Sheath Set was cleared through the FDA 510(k) pathway on March 26, 2004. It is manufactured by Nmt Medical and classified as a Class 2 device under product code DYB.
What It Is
The NMT Medical Transseptal Sheath Set is a medical device designed to facilitate the transseptal puncture procedure, allowing access to the left atrium of the heart. It consists of a sheath and dilator that guide the puncture needle safely through the interatrial septum. This device is crucial in procedures such as catheter ablation for atrial fibrillation and other electrophysiological interventions.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures that require access to the left atrium, such as atrial fibrillation ablation and left atrial appendage closure. Cardiologists and electrophysiologists typically use it in hospital settings, particularly in patients with arrhythmias or structural heart conditions. It is essential for procedures that require precise and safe transseptal access.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring transseptal access to the left atrium. It is suitable for patients undergoing interventions like catheter ablation for arrhythmias.
Practical Considerations
The sheath set comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard transseptal needles and catheters. Clinicians should be trained in transseptal puncture techniques to ensure safe and effective use.
Frequently Asked Questions
What is the NMT Medical Transseptal Sheath Set used for?
It is used to facilitate transseptal access to the left atrium during cardiac procedures such as catheter ablation.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in interventional cardiology and electrophysiology settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring transseptal access to the left atrium, such as catheter ablation for arrhythmias.
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.