📋 FDA Reference
Model Rz Pacemaker Lead Various
Dr. Ing. P. Osypka
Summary: The Model RZ Pacemaker Lead is a cardiac device used for pacing the heart. It is utilized by cardiologists and electrophysiologists to manage arrhythmias in patients requiring pacemaker support.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K823894 ↗
Decision Date ?
April 30, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model RZ Pacemaker Lead was cleared through the FDA 510(k) pathway on April 30, 1983. Manufactured by Dr. Ing. P. Osypka, it is classified as a Class III device.
What It Is
The Model RZ Pacemaker Lead is an implantable lead used in conjunction with pacemakers to deliver electrical impulses to the heart. It is designed to ensure proper cardiac pacing by transmitting signals from the pacemaker to the heart muscle. This device is crucial in managing patients with bradycardia or other rhythm disorders where the heart beats too slowly.
FDA-Cleared Indications
- Use as an implantable lead for delivering electrical stimulation from a pacemaker to the heart.
- Use in patients requiring cardiac pacing for bradycardia or related conduction disorders.
Clinical Applications
- Placement during implantation of a permanent pacemaker.
- Delivery of pacing impulses to the heart muscle in patients with symptomatic slow heart rates.
- Use in patients with heart block or other cardiac conduction disorders requiring electrical stimulation.
- Use as part of a pacemaker system when the selected lead is compatible with the implanted pulse generator.
Practical Considerations
- The lead must be compatible with the selected pacemaker pulse generator and connector system.
- Lead length and configuration should be selected according to the patient's anatomy and the intended cardiac chamber.
- Placement requires imaging and electrical testing to confirm stable positioning, sensing, and pacing thresholds.
- The record provided does not establish MRI compatibility; MRI eligibility must be confirmed from the specific lead and pacemaker system labeling.
- Contraindications, warnings, handling instructions, and available sizes should be verified in the manufacturer's labeling before implantation.
Frequently Asked Questions
What is Model RZ Pacemaker Lead used for?
It is used for pacing the heart in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients needing electrical heart stimulation due to conditions like heart block or slow heart rate.
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.