đź“‹ FDA Reference
heartspan steerable introducer kit
Merit Medical Systems
Summary: The HeartSpan Steerable Introducer Kit is a medical device used to facilitate the introduction and positioning of catheters within the heart. It is primarily used by cardiologists and electrophysiologists during procedures such as cardiac ablations.
FDA Clearance Information
Pathway
510K
Number
K132164 ↗
Decision Date
September 17, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The HeartSpan Steerable Introducer Kit was cleared through the FDA 510(k) pathway on September 17, 2013. Manufactured by Merit Medical Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The HeartSpan Steerable Introducer Kit is designed to aid in the precise placement of catheters within the heart's chambers. It features a steerable sheath that allows for enhanced maneuverability and control during cardiac procedures. This device is particularly useful in navigating the complex anatomy of the heart, making it an essential tool in electrophysiology labs.
Clinical Applications
This device is commonly used in electrophysiology procedures, such as atrial fibrillation ablations, where precise catheter placement is crucial. It is typically utilized in hospital settings, specifically in cardiac catheterization labs. The primary users are cardiologists and electrophysiologists who perform interventions on patients with arrhythmias or other cardiac conditions.
Indications for Use
The FDA indications for the HeartSpan Steerable Introducer Kit involve its use in procedures requiring the introduction and positioning of diagnostic or therapeutic catheters within the heart. It is suitable for patients undergoing cardiac interventions, particularly those with arrhythmias.
Practical Considerations
The HeartSpan Steerable Introducer Kit comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and is designed for single-use to ensure sterility. Clinicians should be familiar with its steering mechanism to maximize its effectiveness during procedures.
Frequently Asked Questions
What is the HeartSpan Steerable Introducer Kit used for?
It is used to facilitate the introduction and precise positioning of catheters within the heart during cardiac procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring the introduction and positioning of catheters within the heart, particularly for cardiac 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.