đź“‹ FDA Reference
talon transseptal sheath
Inari Medical
Summary: The Talon Transseptal Sheath is a medical device used for transseptal access in cardiac procedures. It is typically used by cardiologists and electrophysiologists in catheterization labs.
FDA Clearance Information
Pathway 510K
Number K231108 ↗
Decision Date September 27, 2023
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Talon Transseptal Sheath by Inari Medical was cleared via the FDA 510(k) pathway on September 27, 2023. It is a Class 2 device under product code DYB.
What It Is
The Talon Transseptal Sheath is a specialized catheter designed to facilitate transseptal puncture and access to the left atrium of the heart. It is used in procedures that require crossing the atrial septum, such as catheter ablation for atrial fibrillation or left atrial appendage closure. The sheath provides a stable and reliable conduit for other instruments to pass through the septum safely.
Clinical Applications
Commonly used in electrophysiology labs, the Talon Transseptal Sheath is crucial in procedures like atrial fibrillation ablations, where precise access to the left atrium is necessary. Cardiologists and electrophysiologists utilize this device in hospital settings, particularly in patients with arrhythmias or those undergoing structural heart interventions. It is especially useful in complex cases requiring precise navigation and stability.
Indications for Use
The FDA indications for the Talon Transseptal Sheath include its use in procedures requiring transseptal access to the left atrium. This is particularly relevant for patients undergoing electrophysiological studies or interventions for atrial fibrillation.
Practical Considerations
The Talon Transseptal Sheath is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard transseptal needles and guidewires. Clinicians should be familiar with transseptal puncture techniques to ensure safe and effective use.
Frequently Asked Questions
What is the Talon Transseptal Sheath used for?
It is used for transseptal access in cardiac procedures, such as atrial fibrillation ablation.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring transseptal access to the left atrium, such as electrophysiological studies and interventions.
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.