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oscor medical corp permanent pacing lead
Oscor Medical
Summary: The Oscor Permanent Pacing Lead is a medical device used for cardiac pacing. It is primarily used by cardiologists to manage patients with arrhythmias requiring permanent pacing solutions.
FDA Clearance Information
Pathway
510K
Number
K912867 ↗
Decision Date
February 4, 1992
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Oscor Permanent Pacing Lead was cleared through the FDA 510(k) pathway on February 4, 1992. Manufactured by Oscor Medical, it is a Class III device under product code DTB.
What It Is
The Oscor Permanent Pacing Lead is a device designed to provide long-term cardiac pacing. It is implanted into the heart to deliver electrical impulses, ensuring the heart maintains an adequate rhythm. The lead is typically connected to a pacemaker, which regulates the heart's electrical activity, crucial for patients with conditions like bradycardia.
Clinical Applications
This device is commonly used in cardiology, particularly in procedures involving the implantation of pacemakers. It is utilized in hospital settings, often in cardiac catheterization labs or operating rooms. The primary patient population includes those with symptomatic bradycardia or other rhythm disorders that necessitate permanent pacing.
Indications for Use
The FDA indications suggest that this device is intended for patients who require permanent cardiac pacing. This includes individuals with conditions such as heart block or sick sinus syndrome, where the heart's natural pacing is inadequate.
Practical Considerations
The Oscor Permanent Pacing Lead comes in various sizes to accommodate different patient anatomies. It is compatible with most pacemaker devices, but clinicians should ensure compatibility before implantation. Proper technique during insertion is crucial to avoid complications such as lead dislodgement.
Frequently Asked Questions
What is the Oscor Permanent Pacing Lead used for?
It is used for providing long-term cardiac pacing in patients with rhythm disorders.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
It is indicated for patients needing permanent cardiac pacing due to conditions like heart block or 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.