📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Permanent pacing in patients with symptomatic bradycardia.
- Permanent pacing in patients with heart block or atrioventricular conduction disturbances.
- Use as a transvenous lead connected to a compatible permanent pacemaker generator.
Clinical Applications
- Placement during implantation of a permanent pacemaker system.
- Transvenous pacing of the atrium or ventricle when permanent pacing is clinically indicated.
- Treatment of symptomatic slow heart rhythms caused by conduction disease, including atrioventricular block.
- Securing the pacing lead to cardiac tissue with a retractable screw mechanism.
Practical Considerations
- The lead is available in different lengths to accommodate patient anatomy and the intended cardiac chamber.
- It must be connected to a compatible pacemaker generator and implanted by clinicians trained in transvenous pacing-lead placement.
- Placement typically uses fluoroscopic imaging through venous access, with local anesthesia and sedation or general anesthesia depending on the procedure.
- MRI compatibility should not be assumed from the lead name alone. The complete implanted system, including the generator and lead combination, must be checked against current labeling before MRI.
- Potential complications include lead dislodgement, failure to capture or sense, vascular or cardiac perforation, arrhythmia, infection, thrombosis, and damage to the lead or generator.
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.