đź“‹ FDA Reference
Model P In-Line Bipolar Endocardial Tined Lead
Cook Pacemaker
Summary: The Model P In-Line Bipolar Endocardial Tined Lead is a cardiac device used in pacemaker systems to deliver electrical impulses to the heart. It is primarily used by cardiologists and electrophysiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K915188 ↗
Decision Date ?
September 11, 1992
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on September 11, 1992. Manufactured by Cook Pacemaker, it is classified as a Class III medical device.
What It Is
The Model P In-Line Bipolar Endocardial Tined Lead is a component of pacemaker systems, designed to be implanted in the heart's endocardium. It features tines that help secure the lead in place, ensuring stable electrical contact. The bipolar design allows for more precise sensing and pacing, which is crucial for effective cardiac rhythm management.
FDA-Cleared Indications
- Use as a component of a cardiac pacemaker system when endocardial pacing is indicated.
- Use for delivery of pacing impulses and sensing of cardiac electrical activity.
Clinical Applications
- Endocardial cardiac pacing in patients requiring a permanent pacemaker.
- Pacing support for clinically significant slow heart rates when prescribed as part of a pacemaker system.
- Use with a compatible pacemaker generator for cardiac rhythm management.
Practical Considerations
- The lead must be connected to a compatible pacemaker generator and implanted using appropriate fluoroscopic or other cardiac imaging guidance.
- Tines are intended to help anchor the lead in the heart; correct positioning is important to reduce the risk of dislodgement and loss of capture.
- Available lead lengths and connector specifications should be confirmed against the patient's anatomy and the intended pacemaker generator.
- MRI safety cannot be determined from this record alone. The complete implanted system must be evaluated under current manufacturer labeling before MRI.
- Potential contraindications and risks include infection, bleeding, lead dislodgement, cardiac perforation, abnormal heart rhythms, loss of sensing or capture, and device malfunction.
Frequently Asked Questions
What is the Model P In-Line Bipolar Endocardial Tined Lead used for?
It is used to deliver electrical impulses to the heart in patients requiring pacemaker therapy, particularly for those with bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the management of cardiac rhythm disorders.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to conditions like heart block or sick sinus syndrome.
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.