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Oscor
Summary: The permanent pacing lead models by Oscor are used in cardiac pacing procedures to maintain heart rhythm. They are primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K020669 ↗
Decision Date
March 28, 2002
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Oscor permanent pacing lead models received FDA clearance via the 510(k) pathway on March 28, 2002. They are classified as Class III medical devices.
What It Is
The permanent pacing lead models by Oscor are implantable devices used in cardiac pacing systems. These leads are designed to transmit electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. They are available in various models to accommodate different patient anatomies and clinical needs.
Clinical Applications
These pacing leads are commonly used in procedures to treat bradycardia, where the heart beats too slowly. They are typically implanted by cardiologists or electrophysiologists in hospital settings. The leads are suitable for a wide range of patients, including those with heart block or sick sinus syndrome.
Indications for Use
The FDA indications for these pacing leads include their use in patients requiring chronic cardiac pacing to maintain adequate heart rates. This is particularly relevant for individuals with conditions like heart block or atrial fibrillation with slow ventricular response.
Practical Considerations
The leads come in various sizes to fit different patient anatomies and are compatible with most pacemaker systems. Proper implantation technique is crucial to ensure optimal lead positioning and function. Clinicians should be familiar with the specific model's handling characteristics.
Frequently Asked Questions
What is permanent pacing lead models used for?
They are used to deliver electrical impulses from a pacemaker to the heart to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use these devices in cardiac pacing procedures.
What are the FDA-cleared indications?
They are indicated for patients requiring chronic cardiac pacing to manage conditions like heart block or slow heart rates.
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.