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cordis encor atrial lead
Cordis
Summary: The Cordis Encor Atrial Lead is a medical device used in cardiac pacing systems. It is primarily used by cardiologists to manage arrhythmias in patients requiring atrial pacing.
FDA Clearance Information
Pathway
510K
Number
K811259 ↗
Decision Date
December 27, 1984
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cordis Encor Atrial Lead was cleared through the FDA 510k pathway on December 27, 1984. It is manufactured by Cordis and is classified as a Class III medical device.
What It Is
The Cordis Encor Atrial Lead is a component of cardiac pacing systems, designed to deliver electrical impulses to the atrium of the heart. It helps maintain an adequate heart rate by stimulating the atrial chamber in patients with arrhythmias. The lead is implanted transvenously and connects to a pacemaker device, ensuring proper cardiac rhythm management.
Clinical Applications
This device is commonly used in electrophysiology and cardiology settings for patients with atrial arrhythmias who require pacing support. It is typically used in hospital settings during electrophysiology procedures and is essential for patients with conditions such as sick sinus syndrome or atrial fibrillation requiring rhythm control. The device is suitable for adult and elderly patient populations who need long-term pacing solutions.
Indications for Use
The Cordis Encor Atrial Lead is indicated for patients who require atrial pacing due to arrhythmias. It is specifically used in conditions where the heart's natural pacemaker is not functioning properly, necessitating external pacing support.
Practical Considerations
The Cordis Encor Atrial Lead is available in various lengths to accommodate different patient anatomies. It is compatible with most modern pacemaker devices. Proper implantation technique is crucial to ensure optimal lead placement and function, typically requiring fluoroscopic guidance during the procedure.
Frequently Asked Questions
What is the Cordis Encor Atrial Lead used for?
It is used for atrial pacing in patients with arrhythmias, helping maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in clinical settings.
What are the FDA-cleared indications?
It is indicated for patients requiring atrial pacing due to arrhythmias, such as sick sinus syndrome or atrial fibrillation.
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.