đź“‹ FDA Reference
Lead Endocardial Tined Bipolar 5mm
Pacesetter Systems
Summary: The Lead Endocardial Tined Bipolar 5mm is a cardiac pacing lead used in pacemaker systems, primarily by cardiologists. It is designed for endocardial implantation to facilitate electrical stimulation of the heart.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K801455 ↗
Decision Date ?
October 23, 1980
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
This device was cleared through the FDA 510k pathway on October 23, 1980, by Pacesetter Systems. It is classified as a Class 3 medical device under product code DTB.
What It Is
The Lead Endocardial Tined Bipolar 5mm is a specialized cardiac pacing lead used in conjunction with pacemakers. It features tines that help secure the lead in the heart's endocardial tissue, ensuring stable electrical contact. The bipolar design allows for both sensing and pacing functions, enhancing the precision of cardiac rhythm management.
FDA-Cleared Indications
- Cardiac pacing in patients with symptomatic bradycardia.
- Cardiac pacing in patients with heart block or other conduction disorders requiring pacemaker therapy.
- Endocardial implantation as part of a compatible permanent pacemaker system.
Clinical Applications
- Placement during permanent transvenous pacemaker implantation.
- Electrical stimulation of the endocardium to maintain an appropriate heart rate.
- Bipolar sensing and pacing in cardiac rhythm management.
- Use in hospital or specialized cardiac electrophysiology settings for patients requiring ongoing pacing.
Practical Considerations
- The lead has a tined fixation tip and a listed 5 mm size; correct positioning and stable fixation should be confirmed during implantation.
- It is intended for use with a compatible pacemaker generator and lead connector system; compatibility should be verified before implantation.
- Implantation requires knowledge of venous access, cardiac anatomy, fluoroscopic or other appropriate imaging guidance, and standard pacing techniques.
- MRI safety cannot be determined from this historical FDA record alone. The specific lead, generator, and complete implanted system must be evaluated against current manufacturer MRI labeling.
- Contraindications, warnings, electrical specifications, and expected service life should be confirmed in the original labeling and the current instructions for use.
Frequently Asked Questions
What is the Lead Endocardial Tined Bipolar 5mm used for?
It is used for cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiology and cardiac electrophysiology specialists typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to 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.