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endocardial screw-in lead model 1018t
Pacesetter Systems
Summary: The endocardial screw-in lead model 1018t is a cardiac pacing lead used in pacemaker implantation procedures. It is primarily utilized by cardiologists and electrophysiologists to ensure stable electrical conduction within the heart.
FDA Clearance Information
Pathway
510K
Number
K874205 ↗
Decision Date
February 2, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The endocardial screw-in lead model 1018t was cleared through the FDA 510(k) pathway on February 2, 1988. Manufactured by Pacesetter Systems, it is classified as a Class III medical device.
What It Is
The endocardial screw-in lead model 1018t is a type of cardiac lead used in pacemaker systems. It features a screw-in mechanism that allows for secure attachment to the heart muscle, ensuring reliable electrical conduction. This device plays a critical role in maintaining heart rhythm by delivering electrical impulses from the pacemaker to the heart.
Clinical Applications
This device is commonly used in the implantation of pacemakers, particularly in patients with bradycardia or other arrhythmias requiring pacing. It is typically employed in hospital settings by cardiologists and electrophysiologists. The screw-in design is particularly useful in ensuring lead stability in active patients or those with challenging cardiac anatomy.
Indications for Use
The endocardial screw-in lead is indicated for patients requiring cardiac pacing due to arrhythmias such as bradycardia. It is suitable for individuals who need a reliable and stable connection between the pacemaker and the heart.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with most pacemaker devices. Proper technique during implantation is crucial to ensure secure attachment and optimal performance.
Frequently Asked Questions
What is the endocardial screw-in lead model 1018t used for?
It is used for connecting pacemakers to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
It is indicated for patients needing cardiac pacing due to arrhythmias like bradycardia.
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.