đź“‹ FDA Reference
model d bipolar endocardial lead
Cook Pacemaker
Summary: The Model D Bipolar Endocardial Lead by Cook Pacemaker is a cardiac device used in pacing therapies. It is primarily used by cardiologists to manage arrhythmias in patients requiring pacemaker support.
FDA Clearance Information
Pathway
510K
Number
K811876 ↗
Decision Date
August 3, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model D Bipolar Endocardial Lead was cleared through the FDA 510k pathway on August 3, 1981. It is manufactured by Cook Pacemaker and is classified as a Class 3 device.
What It Is
The Model D Bipolar Endocardial Lead is a cardiac lead designed for implantation in the heart to deliver electrical impulses from a pacemaker. It features a bipolar configuration, which allows for more precise sensing and pacing by using two electrodes. This configuration helps in reducing interference and improving signal quality, making it a reliable choice for patients with arrhythmias.
Clinical Applications
This device is commonly used in cardiac pacing procedures, particularly for patients with bradycardia or other arrhythmias requiring regular pacing. It is typically used in hospital settings by cardiologists and electrophysiologists. The device is suitable for adult patients who require long-term pacing support, and it is often part of a comprehensive pacemaker system.
Indications for Use
The Model D Bipolar Endocardial Lead is indicated for patients who need cardiac pacing due to conditions like bradycardia or heart block. It is intended for use in individuals who require stable and reliable heart rate management.
Practical Considerations
Clinicians should consider the lead's compatibility with the pacemaker generator being used. Proper sizing and placement are crucial for optimal performance, and the device should be handled with care during implantation to avoid damage.
Related Literature
The linked study, 'Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar,' investigates the performance of a similar bipolar lead. Although specific details are unavailable, such studies typically assess lead efficacy, safety, and long-term outcomes. Limitations may include lack of detailed results and applicability to the Model D lead.
Frequently Asked Questions
What is the Model D Bipolar Endocardial Lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists in hospital settings 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.