đź“‹ FDA Reference
oscor medical unipolar permanent pacing lead-conne
Oscor Medical
Summary: The Oscor Medical Unipolar Permanent Pacing Lead is a device used in cardiac pacing to maintain heart rhythm. It is primarily used by cardiologists in hospital settings for patients requiring long-term pacing solutions.
FDA Clearance Information
Pathway
510K
Number
K854128 ↗
Decision Date
February 26, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Oscor Medical Unipolar Permanent Pacing Lead was cleared through the FDA 510k pathway on February 26, 1986. Manufactured by Oscor Medical, it is classified as a Class III device.
What It Is
The Oscor Medical Unipolar Permanent Pacing Lead is a cardiac device designed to deliver electrical impulses to the heart muscle to regulate heartbeats. It connects to a pacemaker and is implanted in patients who have arrhythmias or other heart rhythm disorders. The lead is unipolar, meaning it uses a single electrode to deliver pacing signals.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology, for patients who require permanent pacing due to conditions like bradycardia or heart block. It is typically utilized in hospital settings during surgical implantation procedures. The patient population includes those with chronic heart rhythm disorders who need ongoing pacing support.
Indications for Use
The FDA indications for this device include its use in patients who require permanent cardiac pacing to maintain adequate heart rhythm. It is suitable for individuals with conditions such as bradycardia or heart block.
Practical Considerations
The unipolar lead is compatible with most pacemaker generators. It is important to ensure proper sizing and placement during implantation to optimize performance and minimize complications. Clinicians should be familiar with the specific implantation technique for unipolar leads.
Frequently Asked Questions
What is the Oscor Medical Unipolar Permanent Pacing Lead used for?
It is used for delivering electrical impulses to the heart to regulate heart rhythm in patients requiring permanent pacing.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients who need permanent cardiac pacing to maintain heart rhythm, such as those with 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.