đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Cardiac pacing for patients with symptomatic bradycardia.
- Cardiac pacing for patients with heart block or other clinically significant conduction disturbances.
- Use as part of a permanent endocardial pacemaker system when ventricular pacing is required.
Clinical Applications
- Transvenous implantation as part of a permanent pacemaker system.
- Pacing the endocardial surface of the heart in patients who require long-term rhythm support.
- Treatment of symptomatic slow heart rates associated with bradycardia.
- Treatment of heart block requiring electrical pacing.
Practical Considerations
- The lead is available in different lengths to accommodate patient anatomy and the selected venous access route.
- Implantation generally uses fluoroscopic imaging to guide the lead through a vein into the cardiac chamber and confirm final position.
- The lead must be connected to a compatible pacemaker generator and handled according to the manufacturer's instructions; compatibility should be verified rather than assumed.
- The FDA record provided does not establish MRI safety. MRI eligibility should be determined from the complete lead-generator system and current manufacturer labeling.
- Potential contraindications and complications include unsuitable venous or cardiac anatomy, infection, bleeding, lead dislodgement, perforation, thrombosis, and abnormal pacing or sensing.
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.