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modified oscor py pacing leads modification
Oscor Medical
Summary: The modified Oscor Py pacing leads are used for cardiac pacing in patients requiring temporary or permanent pacing. They are primarily used by cardiologists and cardiac surgeons.
FDA Clearance Information
Pathway
510K
Number
K913158 ↗
Decision Date
September 23, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The modified Oscor Py pacing leads were cleared through the FDA 510(k) pathway on September 23, 1991. Manufactured by Oscor Medical, this Class 3 device is intended for cardiac pacing.
What It Is
The modified Oscor Py pacing leads are specialized medical devices used to deliver electrical impulses to the heart to maintain an adequate heart rate. They consist of insulated wires that connect the heart to an external pacemaker or an implantable device. These leads are crucial in managing arrhythmias and ensuring proper cardiac function in patients with heart rhythm disorders.
Clinical Applications
These pacing leads are commonly used in procedures involving temporary or permanent cardiac pacing, such as in patients with bradycardia or heart block. They are typically utilized in hospital settings, including cardiac catheterization labs and operating rooms. Cardiologists and cardiac surgeons are the primary users, often in the context of managing acute or chronic arrhythmias.
Indications for Use
The FDA indications suggest these leads are intended for patients who require pacing due to conditions like slow heart rates or heart block. They are suitable for both temporary pacing during acute episodes and permanent pacing solutions.
Practical Considerations
The leads come in various lengths and configurations to accommodate different patient anatomies and procedural needs. Compatibility with specific pacemaker models should be verified. Proper technique in lead placement is crucial to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is modified Oscor Py pacing leads used for?
They are used for cardiac pacing in patients with arrhythmias or heart block to maintain adequate heart rate.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use these leads in hospital settings.
What are the FDA-cleared indications?
They are indicated for patients requiring temporary or permanent cardiac pacing due to conditions like 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.