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djp unipolar
Biotronik Sales
Summary: The DJP Unipolar is a medical device used primarily in cardiovascular procedures. It is utilized by cardiologists and interventional radiologists to manage specific heart conditions.
FDA Clearance Information
Pathway 510K
Number K853567 ↗
Decision Date May 7, 1986
Product Code DTB
Device Class Class 3
Evidence 0 studies
The DJP Unipolar, manufactured by Biotronik Sales, was cleared through the FDA 510(k) pathway on May 7, 1986. It is classified as a Class III device under product code DTB.
What It Is
The DJP Unipolar is a type of cardiac device used in the management of heart rhythm disorders. It operates by delivering electrical impulses to the heart muscle to ensure proper heart rate and rhythm. This device is crucial in treating patients with arrhythmias, providing a reliable solution to maintain cardiac function.
Clinical Applications
The DJP Unipolar is commonly used in interventional cardiology and electrophysiology settings. It is particularly beneficial for patients with bradycardia or other arrhythmias requiring pacing. The device is typically implanted in a hospital setting, where cardiologists or electrophysiologists perform the procedure. It is suitable for adult patients who require long-term cardiac pacing.
Indications for Use
The DJP Unipolar is indicated for patients with conditions such as bradycardia, where the heart beats too slowly. It helps maintain an adequate heart rate by providing electrical stimulation to the heart muscle.
Practical Considerations
The DJP Unipolar comes in various sizes to accommodate different patient anatomies. It is compatible with standard pacing leads and requires careful implantation technique to ensure optimal performance and patient safety.
Frequently Asked Questions
What is DJP Unipolar used for?
The DJP Unipolar is used to manage heart rhythm disorders, particularly in patients with bradycardia, by providing electrical pacing to the heart.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use the DJP Unipolar in interventional cardiology and electrophysiology settings.
What are the FDA-cleared indications?
The device is indicated for patients with conditions like bradycardia, where it helps maintain an adequate heart rate through electrical stimulation.
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.