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label change unipolar endocardial lead djp 53-up
Biotronik, Gmbh &
Summary: The Unipolar Endocardial Lead DJP 53-UP is a cardiac lead used in pacemaker systems. It is primarily used by cardiologists to manage arrhythmias in patients requiring pacing therapy.
FDA Clearance Information
Pathway
510K
Number
K903928 ↗
Decision Date
October 16, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Unipolar Endocardial Lead DJP 53-UP by Biotronik was cleared through the FDA 510(k) pathway on October 16, 1990. It is a Class III device under product code DTB.
What It Is
The Unipolar Endocardial Lead DJP 53-UP is a type of cardiac lead designed for use in pacemaker systems. It functions by transmitting electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. The lead is unipolar, meaning it has a single electrode that contacts the heart tissue, which is crucial for pacing therapy.
Clinical Applications
This device is commonly used in cardiology, particularly in the management of patients with bradycardia or other arrhythmias that require pacing. It is typically implanted in hospital settings by electrophysiologists or cardiologists. The device is suitable for adult patients who need long-term pacing therapy.
Indications for Use
The Unipolar Endocardial Lead DJP 53-UP is indicated for patients who require cardiac pacing due to arrhythmias such as bradycardia. It is used in conjunction with a pacemaker to help maintain an adequate heart rate.
Practical Considerations
When using the Unipolar Endocardial Lead DJP 53-UP, clinicians should consider the lead's compatibility with the pacemaker system being used. Proper sizing and placement technique are essential for optimal performance and patient outcomes.
Frequently Asked Questions
What is Unipolar Endocardial Lead DJP 53-UP used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to arrhythmias 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.