📋 FDA Reference
Heartspan Steerable Introducer Kit
Contact Merit Medical Systems, Inc. ↗ Compare similar devices
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 ?
510(k)
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.
FDA-Cleared Indications
- Used to facilitate the introduction and positioning of catheters within the heart.
- Intended for use with diagnostic or therapeutic catheters during cardiac catheter-based procedures.
Clinical Applications
- Introducing and positioning electrophysiology catheters in the heart.
- Providing steerable access during catheter-based cardiac interventions.
- Supporting diagnostic cardiac catheter procedures that require controlled catheter positioning.
- Supporting therapeutic cardiac catheter procedures, including procedures for cardiac rhythm disorders when used with compatible catheters.
Practical Considerations
- The kit is available in different sheath sizes and configurations; clinicians select the appropriate option based on the access route, catheter size, and patient anatomy.
- It is designed for use with compatible diagnostic and therapeutic catheters. Compatibility should be confirmed in the current manufacturer instructions for use.
- The sheath is advanced and steered under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- The device is intended for single use and should not be resterilized or reused.
- MRI safety and conditional-use information should be verified in the current product labeling; do not assume the device is MRI safe based solely on its FDA clearance.
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.