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dnp 60-b unipolar endocardial lead
Biotronik, Gmbh &
Summary: The dnp 60-b unipolar endocardial lead is a cardiac device used in pacemaker systems to deliver electrical impulses to the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K901709 ↗
Decision Date
May 22, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The dnp 60-b unipolar endocardial lead was cleared through the FDA 510(k) pathway on May 22, 1990. Manufactured by Biotronik, Gmbh, it is classified as a Class III device.
What It Is
The dnp 60-b unipolar endocardial lead is a component of a pacemaker system, designed to transmit electrical impulses from the pacemaker to the heart muscle. It is implanted within the heart's endocardial surface and is crucial for maintaining heart rhythm in patients with arrhythmias. The lead's unipolar design means it uses a single electrode to deliver pacing signals.
Clinical Applications
This device is commonly used in cardiology, particularly in the management of bradycardia or heart block where pacing is necessary. It is typically implanted in a hospital setting by an electrophysiologist or cardiologist. The patient population includes those with symptomatic bradycardia, heart block, or other conditions requiring pacing support.
Indications for Use
The dnp 60-b lead is indicated for patients who require cardiac pacing due to conditions like bradycardia or heart block. It is used to ensure proper heart rhythm and improve cardiac output in affected individuals.
Practical Considerations
The dnp 60-b lead is available in various lengths to accommodate different patient anatomies. It is compatible with specific pacemaker models, and proper technique during implantation is crucial to ensure optimal function and minimize complications.
Frequently Asked Questions
What is dnp 60-b unipolar endocardial lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to conditions like 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.