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modified oscor py pacing leads
Oscor Medical
Summary: The modified Oscor Py pacing leads are used in cardiac pacing procedures to deliver electrical impulses to the heart. They are primarily used by cardiologists in hospital settings for patients requiring temporary or permanent cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K862330 ↗
Decision Date
August 8, 1986
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 August 8, 1986. Manufactured by Oscor Medical, this device is classified as Class III under product code DTB.
What It Is
The modified Oscor Py pacing leads are specialized wires designed to deliver electrical impulses from a pacemaker to the heart muscle. These leads are crucial in ensuring proper cardiac rhythm management in patients with arrhythmias. They are typically inserted transvenously and positioned in the heart chambers to maintain effective pacing.
Clinical Applications
These pacing leads are commonly used in procedures involving temporary or permanent pacemaker implantation. They are essential in managing bradycardia and other rhythm disorders. Cardiologists and electrophysiologists primarily use these leads in hospital settings, particularly in cardiac catheterization labs or operating rooms.
Indications for Use
The FDA indications suggest these leads are intended for patients requiring cardiac pacing due to arrhythmias such as bradycardia. They are used in both temporary and permanent pacing scenarios.
Practical Considerations
The leads come in various lengths and configurations to accommodate different patient anatomies and pacing requirements. Compatibility with specific pacemaker models should be confirmed prior to use. 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 to deliver electrical impulses to the heart in patients requiring cardiac pacing due to arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads in hospital settings.
What are the FDA-cleared indications?
They are indicated for patients requiring cardiac pacing, particularly those with arrhythmias like 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.