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perm endocardial unipolar tined atrial
Diag
Summary: The perm endocardial unipolar tined atrial device by Diag is used in cardiac pacing. It is typically utilized by cardiologists for patients requiring atrial pacing.
FDA Clearance Information
Pathway 510K
Number K812270 ↗
Decision Date September 16, 1981
Product Code DTB
Device Class Class 3
Evidence 0 studies
The device was cleared via the FDA 510k pathway on September 16, 1981. Manufactured by Diag, it is classified as a Class III device under product code DTB.
What It Is
The perm endocardial unipolar tined atrial device is a cardiac pacing lead designed for permanent implantation in the atrium. It features a unipolar configuration with tines that help secure the lead in place. This device is crucial for maintaining heart rhythm in patients with atrial arrhythmias.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology labs and cardiac surgery settings. It is suitable for patients who require atrial pacing due to conditions like atrial fibrillation or sick sinus syndrome. The device is typically implanted during a minimally invasive procedure by a cardiologist or electrophysiologist.
Indications for Use
The device is indicated for patients who need atrial pacing to manage arrhythmias. It is suitable for individuals with conditions that affect the heart's electrical conduction system, leading to irregular heartbeats.
Practical Considerations
The device is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Proper placement and secure fixation of the tines are crucial for optimal performance and longevity.
Frequently Asked Questions
What is the perm endocardial unipolar tined atrial used for?
It is used for permanent atrial pacing in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring atrial pacing due to 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.