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laserpor ap atrial endocard electr ld
Telectronics
Summary: The Laserpor AP Atrial Endocardial Electrode by Telectronics is a medical device used in cardiac procedures to manage atrial arrhythmias. It is primarily utilized by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K820121 ↗
Decision Date
February 12, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Laserpor AP Atrial Endocardial Electrode was cleared through the FDA 510(k) pathway on February 12, 1982. Manufactured by Telectronics, it is classified as a Class III device under product code DTB.
What It Is
The Laserpor AP Atrial Endocardial Electrode is a specialized cardiac device designed to deliver electrical impulses to the atrial endocardium. It is used in the management of atrial arrhythmias by facilitating precise electrical conduction to restore normal heart rhythm. The device is typically inserted via a minimally invasive procedure and is integral in cardiac electrophysiology.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures to treat atrial fibrillation or flutter. It is utilized by cardiologists and electrophysiologists in both hospital and outpatient settings. The device is suitable for adult patients with atrial arrhythmias requiring precise electrical intervention.
Indications for Use
The FDA indications suggest that this device is intended for patients with atrial arrhythmias, such as atrial fibrillation or flutter, who require electrical stimulation to manage their condition. It is particularly useful in cases where medication alone is insufficient.
Practical Considerations
Clinicians should consider the electrode's compatibility with existing cardiac pacing systems. Proper sizing and placement are crucial for optimal performance, and training in electrophysiology techniques is recommended for effective use.
Frequently Asked Questions
What is the Laserpor AP Atrial Endocardial Electrode used for?
It is used to manage atrial arrhythmias by delivering electrical impulses to the heart's atrial endocardium.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for patients with atrial arrhythmias requiring electrical stimulation, such as atrial fibrillation or flutter.
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.