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model f unipolar endocardial lead-
Cook Pacemaker
Summary: The Model F Unipolar Endocardial Lead by Cook Pacemaker is a cardiac lead used in pacemaker systems to transmit electrical impulses to the heart. It is primarily used by cardiologists for patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K832255 ↗
Decision Date
August 12, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model F Unipolar Endocardial Lead was cleared through the FDA 510(k) pathway on August 12, 1983, by Cook Pacemaker. It is a Class III medical device.
What It Is
The Model F Unipolar Endocardial Lead is a component of pacemaker systems, designed to deliver electrical impulses from the pacemaker to the heart muscle. It is a unipolar lead, meaning it uses a single electrode to transmit electrical signals. This device is crucial for maintaining heart rhythm in patients with arrhythmias or other cardiac conduction disorders.
Clinical Applications
This device is commonly used in the field of cardiology, particularly in electrophysiology and cardiac surgery. It is typically implanted in hospital settings during pacemaker insertion procedures. The primary patient population includes those with bradycardia, heart block, or other conditions requiring cardiac pacing.
Indications for Use
The FDA indications suggest that this device is intended for patients who need cardiac pacing due to conditions like slow heart rate or heart block. It helps ensure the heart beats at a regular pace.
Practical Considerations
When considering this device, clinicians should be aware of its compatibility with specific pacemaker models. Proper technique during implantation is crucial to ensure stable lead placement and function. The lead's unipolar design may influence the choice of pacemaker settings.
Frequently Asked Questions
What is the Model F Unipolar Endocardial Lead used for?
It is used to deliver electrical impulses from a pacemaker to the heart to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, 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.