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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
510K
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.
Clinical Applications
This device is commonly used in cardiac electrophysiology and cardiology settings, particularly for patients requiring long-term cardiac pacing. It is typically implanted during procedures in hospitals or specialized cardiac centers. The device is suitable for a wide range of patients, including those with bradycardia or heart block, who need consistent heart rate regulation.
Indications for Use
The device is indicated for patients who require cardiac pacing due to conditions like bradycardia or heart block. It is designed to be implanted in the heart to help maintain an appropriate heart rate and rhythm.
Practical Considerations
The lead is typically 5mm in size and is compatible with most pacemaker systems. Clinicians should ensure proper placement and secure fixation of the tines during implantation to optimize device performance. Familiarity with cardiac anatomy and pacing techniques is essential for successful 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.