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model 833 endocardial tined lead
Pacesetter Systems
Summary: The Model 833 Endocardial Tined Lead is a cardiac pacing lead used in conjunction with pacemakers to manage arrhythmias. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K812815 ↗
Decision Date
October 29, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 833 Endocardial Tined Lead by Pacesetter Systems was cleared via the FDA 510(k) pathway on October 29, 1981. It is classified as a Class III device under product code DTB.
What It Is
The Model 833 Endocardial Tined Lead is a specialized lead used in cardiac pacing systems. It is designed to be implanted in the heart's endocardial surface, where its tines help secure it in place. This lead transmits electrical impulses from the pacemaker to the heart muscle, helping to regulate heart rhythms in patients with arrhythmias.
Clinical Applications
This device is primarily used in the management of bradycardia, where it helps maintain adequate heart rates. It is commonly used in cardiology, particularly in electrophysiology labs and during cardiac surgery. The typical patient population includes those with symptomatic bradycardia or heart block, often in a hospital or specialized cardiac center.
Indications for Use
The Model 833 Endocardial Tined Lead is indicated for patients requiring cardiac pacing due to conditions like bradycardia or heart block. It is suitable for those who need long-term pacing support.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker systems, and implantation requires fluoroscopic guidance to ensure proper placement. Clinicians should be familiar with lead handling and fixation techniques.
Frequently Asked Questions
What is the Model 833 Endocardial Tined Lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, use this device in hospital settings.
What are the FDA-cleared indications?
The device 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.