📋 FDA Reference
Biopolar Tined Endocardial Lead 403b 60
Siemens Elema Ab
Summary: The Biopolar Tined Endocardial Lead 403b 60 is a cardiac lead used in pacemaker systems to deliver electrical impulses to the heart. It is primarily used by cardiologists in the management of patients with arrhythmias.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K820767 ↗
Decision Date ?
April 9, 1982
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Biopolar Tined Endocardial Lead 403b 60 was cleared through the FDA 510(k) pathway on April 9, 1982. Manufactured by Siemens Elema Ab, it is classified as a Class III device.
What It Is
The Biopolar Tined Endocardial Lead 403b 60 is a specialized cardiac lead designed to be implanted in the heart's endocardial surface. It features tines that help secure the lead in place, ensuring stable electrical contact with the heart tissue. This lead is used in conjunction with pacemakers to manage heart rhythm disorders, delivering electrical impulses to maintain an appropriate heart rate.
FDA-Cleared Indications
- Use in patients who require cardiac pacing for rhythm disorders such as bradycardia or heart block.
- Use as a component of a compatible pacemaker system to deliver electrical stimulation to the heart.
Clinical Applications
- Endocardial lead placement during permanent pacemaker implantation.
- Cardiac pacing for symptomatic bradycardia.
- Cardiac pacing for atrioventricular or other clinically significant heart block.
- Connection to a compatible pacemaker generator for delivery of therapeutic electrical impulses.
Practical Considerations
- The lead must be matched to a compatible pacemaker generator and system configuration.
- Implantation requires appropriate venous access and positioning within the heart under fluoroscopic and electrocardiographic guidance.
- The tined design is intended to help stabilize the lead, but lead displacement, malfunction, infection and other implantation-related complications remain possible.
- MRI safety cannot be determined from the device name alone. This older lead should be considered non-MRI-conditional unless current manufacturer labeling and the complete implanted system confirm otherwise.
- Lead size, electrical characteristics, patient anatomy, venous access and the condition of any existing pacing system should be evaluated before implantation or revision.
Frequently Asked Questions
What is the Biopolar Tined Endocardial Lead 403b 60 used for?
It is used in pacemaker systems to deliver electrical impulses to the heart, helping to manage arrhythmias like bradycardia.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, commonly use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to arrhythmias such as 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.