📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an atrial endocardial electrode for delivering electrical stimulation to the atrium.
- Use with compatible cardiac pacing systems when atrial endocardial stimulation is clinically indicated.
Clinical Applications
- Atrial pacing in patients who require electrical stimulation of the atrium.
- Placement of an endocardial electrode within the atrium during cardiac pacing procedures.
- Use with compatible cardiac pacing equipment under the direction of a qualified cardiac electrophysiology team.
Practical Considerations
- The record identifies this as a Class III device cleared under 510(k) K820121; current availability, labeling, and compatibility should be confirmed with the FDA and manufacturer records.
- The electrode must be compatible with the intended pacing system and connector configuration.
- Placement requires appropriate training in intracardiac lead or electrode positioning and confirmation of electrical performance.
- The record does not provide specific dimensions, sizes, MRI-conditional labeling, durability, or contraindications.
- MRI safety should not be assumed. The complete implanted system and current manufacturer labeling must be reviewed before MRI.
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.