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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
510K
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.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology labs and cardiac surgery settings. It is utilized in patients requiring pacemaker implantation due to conditions like bradycardia or heart block. The lead is suitable for adult and pediatric populations, depending on the specific clinical scenario and patient anatomy.
Indications for Use
The Biopolar Tined Endocardial Lead 403b 60 is indicated for use in patients who require cardiac pacing due to arrhythmias such as bradycardia or heart block. It is designed to help maintain a regular heart rhythm by delivering electrical impulses directly to the heart muscle.
Practical Considerations
Clinicians should consider lead size and compatibility with the chosen pacemaker system. Proper technique during implantation is crucial for ensuring lead stability and function. The tined design aids in securing the lead, reducing the risk of dislodgement.
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.