đź“‹ FDA Reference
heartspan steerable introducer kit
Thomas Medical Products
Summary: The HeartSpan Steerable Introducer Kit is a medical device used to facilitate the placement of catheters in the heart. It is primarily used by cardiologists during procedures like catheter ablation.
FDA Clearance Information
Pathway
510K
Number
K122431 ↗
Decision Date
January 29, 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 January 29, 2013. Manufactured by Thomas Medical Products, 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. It features a steerable sheath that allows for enhanced maneuverability and control during cardiac procedures. This device is particularly useful in electrophysiology labs where precision is crucial for successful outcomes.
Clinical Applications
This device is commonly used in electrophysiology procedures, such as catheter ablation, to treat arrhythmias. Cardiologists and electrophysiologists use it in hospital settings, particularly in catheterization labs, to improve access to specific areas of the heart. It is suitable for adult patients requiring intervention for cardiac arrhythmias.
Indications for Use
The HeartSpan Steerable Introducer Kit is indicated for use in patients undergoing procedures that require catheter placement in the heart, such as those with arrhythmias needing ablation therapy. It helps in navigating the complex cardiac anatomy.
Practical Considerations
The device is available 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 steerable sheath techniques for optimal use.
Frequently Asked Questions
What is the HeartSpan Steerable Introducer Kit used for?
It is used to facilitate the placement of catheters in the heart during procedures such as catheter ablation.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during cardiac procedures.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring catheter placement in the heart, particularly for treating 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.