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oscor permanent pacing lead rz model series
Oscor
Summary: The Oscor Permanent Pacing Lead RZ Model Series is a cardiac pacing lead used in patients requiring permanent cardiac pacing. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K003918 ↗
Decision Date
May 22, 2001
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Oscor Permanent Pacing Lead RZ Model Series was cleared through the FDA 510k pathway on May 22, 2001. It is manufactured by Oscor and classified as a Class III medical device.
What It Is
The Oscor Permanent Pacing Lead RZ Model Series is a medical device designed for permanent cardiac pacing. It works by delivering electrical impulses to the heart muscle to maintain an adequate heart rate and rhythm. The lead is implanted into the heart and connected to a pacemaker, which regulates the electrical impulses. This device is crucial for patients with arrhythmias or heart block who require consistent cardiac pacing.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically perform these procedures in a hospital setting. The device is suitable for adult and geriatric populations who have conditions that necessitate permanent pacing to maintain cardiac function.
Indications for Use
The FDA indications for this device include its use in patients who require permanent cardiac pacing due to conditions like bradycardia or heart block. It is intended for individuals who need a reliable means of maintaining heart rhythm.
Practical Considerations
The Oscor Permanent Pacing Lead RZ Model Series comes in various sizes to accommodate different patient anatomies. It is compatible with most modern pacemakers. Clinicians should consider the patient's venous anatomy and the lead's compatibility with the chosen pacemaker system during implantation.
Frequently Asked Questions
What is Oscor Permanent Pacing Lead RZ Model Series used for?
It is used for permanent cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring permanent cardiac pacing due to conditions such as bradycardia or heart block.
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.