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model c unipolar endocardial lead
Cook Pacemaker
Summary: The Model C Unipolar Endocardial Lead is a cardiac device used in pacing systems to deliver electrical impulses to the heart. It is primarily used by cardiologists in patients requiring pacemaker therapy.
FDA Clearance Information
Pathway
510K
Number
K811877 ↗
Decision Date
August 3, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model C Unipolar Endocardial Lead was cleared through the FDA 510k pathway on August 3, 1981. Manufactured by Cook Pacemaker, it is classified as a Class III device.
What It Is
The Model C Unipolar Endocardial Lead is a component of a pacemaker system designed to transmit electrical impulses from the pacemaker to the heart muscle. It consists of a single electrode that makes contact with the heart's endocardial surface, facilitating proper cardiac rhythm management. This device is crucial for patients with arrhythmias or heart block who require consistent pacing support.
Clinical Applications
This lead is commonly used in cardiology, particularly in electrophysiology and interventional cardiology settings. It is typically implanted in patients with symptomatic bradycardia or heart block. The procedure is performed in a hospital setting, often in a cardiac catheterization lab or operating room, and is essential for patients who need long-term cardiac pacing.
Indications for Use
The Model C Unipolar Endocardial Lead is indicated for patients who require electrical pacing of the heart due to conditions like bradycardia or atrioventricular block. It is used to ensure the heart maintains an adequate rate and rhythm.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with most pacemaker generators. Proper placement technique is crucial to ensure optimal performance and longevity of the device. Clinicians should be familiar with the handling and insertion techniques specific to unipolar leads.
Frequently Asked Questions
What is Model C Unipolar Endocardial Lead used for?
It is used for delivering electrical impulses to the heart in patients requiring pacemaker therapy.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and interventional cardiology, typically use this device.
What are the FDA-cleared indications?
It is indicated for patients needing cardiac pacing due to conditions like bradycardia or heart block.
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.