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navigo 12f steerable intracardiac catheter introducer kit s12fs-01
Synaptic Medical
Summary: The navigo 12f steerable intracardiac catheter introducer kit is a medical device used to facilitate the introduction of catheters into the heart. It is primarily used by cardiologists and electrophysiologists during procedures such as catheter ablation.
FDA Clearance Information
Pathway
510K
Number
K233708 ↗
Decision Date
February 16, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The navigo 12f steerable intracardiac catheter introducer kit by Synaptic Medical was cleared through the FDA 510(k) pathway on February 16, 2024. It is classified as a Class 2 device under product code DYB.
What It Is
The navigo 12f steerable intracardiac catheter introducer kit is designed to aid in the insertion and positioning of catheters within the heart. It features a steerable sheath that allows for precise navigation through the cardiac anatomy, enhancing the safety and efficacy of intracardiac procedures. This device is particularly useful in complex cardiac interventions where precise catheter placement is critical.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as catheter ablation for arrhythmias. It is also utilized in structural heart interventions and other cardiac catheterization procedures. The navigo 12f is suitable for adult patients undergoing these specialized cardiac procedures, typically in a hospital or specialized cardiac center setting.
Indications for Use
The FDA-cleared indications for this device include facilitating the introduction and placement of catheters in the heart. It is intended for use in patients requiring cardiac catheterization for diagnostic or therapeutic purposes.
Practical Considerations
The navigo 12f introducer kit is typically available in various lengths and diameters to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheter types and should be used by clinicians trained in intracardiac procedures. Proper technique and familiarity with the device's steerable features are essential for optimal outcomes.
Frequently Asked Questions
What is the navigo 12f steerable intracardiac catheter introducer kit used for?
It is used to facilitate the introduction and precise placement of catheters within the heart during cardiac procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in cardiac catheterization and electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction and placement of catheters in the heart for diagnostic or therapeutic procedures.
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.