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endocardial screw-in lead 859 861
Pacesetter Systems
Summary: The endocardial screw-in lead 859 861 is a cardiac pacing lead used in cardiac electrophysiology. It is typically used by cardiologists to ensure stable electrical connection in pacemaker procedures.
FDA Clearance Information
Pathway
510K
Number
K833824 ↗
Decision Date
December 1, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The endocardial screw-in lead 859 861 was cleared via the FDA 510(k) pathway on December 1, 1983. Manufactured by Pacesetter Systems, it is classified as a Class III device.
What It Is
The endocardial screw-in lead 859 861 is a type of cardiac pacing lead designed to be inserted into the heart's endocardium. It features a screw-in mechanism to secure the lead tip to the heart tissue, ensuring stable electrical conduction. This device is crucial in pacing systems, providing reliable electrical signals to regulate heart rhythms.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically use it in hospital settings, including cardiac catheterization labs. It is suitable for adult and elderly patients who require long-term cardiac pacing.
Indications for Use
The endocardial screw-in lead is indicated for patients who need cardiac pacing due to conditions like bradycardia or atrioventricular block. It helps maintain appropriate heart rates by delivering electrical impulses directly to the heart muscle.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Proper technique in screwing the lead into the endocardium is essential to ensure stability and reduce the risk of dislodgement.
Frequently Asked Questions
What is the endocardial screw-in lead 859 861 used for?
It is used for cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
It is indicated for use in patients requiring cardiac pacing due to bradycardia or atrioventricular 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.