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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
510K
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.
Clinical Applications
This pacemaker lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with symptomatic bradycardia or heart block. It is primarily used by cardiologists and electrophysiologists in hospital settings. The device is suitable for adult and pediatric patients who require long-term pacing support.
Indications for Use
The FDA indications suggest that this device is intended for patients who need electrical stimulation of the heart due to conditions like heart block or slow heart rate. It is particularly beneficial for those who do not respond to medication or other non-invasive treatments.
Practical Considerations
When considering the Model RZ Pacemaker Lead, clinicians should note its compatibility with various pacemaker models. Proper lead placement and securing technique are crucial for optimal function. Sizing may vary, so it's important to select the appropriate lead length based on patient anatomy.
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.