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siemens-elema endocardial lead 402s
Siemens Elema Ab
Summary: The Siemens-Elema Endocardial Lead 402S is a cardiac pacing lead used in conjunction with pacemakers to manage heart rhythm disorders. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K803042 ↗
Decision Date
December 22, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Siemens-Elema Endocardial Lead 402S was cleared through the FDA 510(k) pathway on December 22, 1980. Manufactured by Siemens Elema Ab, it is classified as a Class III device under product code DTB.
What It Is
The Siemens-Elema Endocardial Lead 402S is a medical device designed for cardiac pacing. It functions as an electrical conductor, delivering impulses from a pacemaker to the heart muscle to regulate heartbeats. The lead is inserted into the heart via the venous system and positioned endocardially to ensure effective pacing.
Clinical Applications
This device is commonly used in the management of bradycardia and other arrhythmias requiring pacing support. It is typically utilized in cardiology departments, especially in electrophysiology labs, and is suitable for adult patients with heart rhythm disorders. The lead is an integral component of pacemaker implantation procedures.
Indications for Use
The Siemens-Elema Endocardial Lead 402S is indicated for patients who require cardiac pacing due to conditions like bradycardia. It is used in patients who have a pacemaker implanted to ensure proper heart rhythm management.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker models, but clinicians should verify compatibility before use. Proper technique during insertion is crucial to avoid complications such as lead dislodgement.
Frequently Asked Questions
What is Siemens-Elema Endocardial Lead 402S used for?
It is used for cardiac pacing in patients with heart rhythm disorders, delivering electrical impulses from a pacemaker to the heart.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like bradycardia.
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.