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oscor permanent retractable screw-in pacing lead model pr
Oscor Medical
Summary: The Oscor Permanent Retractable Screw-In Pacing Lead is a cardiac device used for pacing the heart. It is primarily used by cardiologists in patients requiring permanent pacing support.
FDA Clearance Information
Pathway
510K
Number
K964107 ↗
Decision Date
April 1, 1997
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on April 1, 1997, by Oscor Medical. It is classified as a Class III device under product code DTB.
What It Is
The Oscor Permanent Retractable Screw-In Pacing Lead is a specialized cardiac lead used in permanent pacemaker systems. It features a retractable screw mechanism that allows for secure attachment to the heart tissue, ensuring stable electrical conduction. This device is crucial for patients with arrhythmias or heart block who require consistent pacing to maintain a regular heart rhythm.
Clinical Applications
This pacing lead is commonly used in cardiac electrophysiology and cardiology settings, particularly during pacemaker implantation procedures. It is suitable for patients with conditions such as bradycardia or atrioventricular block. The device is typically used in hospital settings, including cardiac catheterization labs and operating rooms, and is essential for ensuring effective pacing therapy in adult and elderly populations.
Indications for Use
The FDA indications suggest this device is intended for patients who need permanent pacing support due to conditions like heart block or severe bradycardia. It is designed to provide reliable electrical conduction to maintain heart rhythm.
Practical Considerations
The Oscor pacing lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Clinicians should be familiar with the screw-in technique to ensure proper lead placement and stability.
Frequently Asked Questions
What is the Oscor Permanent Retractable Screw-In Pacing Lead used for?
It is used for providing permanent pacing support in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for patients needing permanent pacing due to conditions like heart block or severe 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.