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model zy pacemaker lead-various
Oscor
Summary: The Model ZY Pacemaker Lead by Oscor is a medical device used to connect a pacemaker to the heart muscle, facilitating electrical stimulation. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K823890 ↗
Decision Date
March 31, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model ZY Pacemaker Lead was cleared by the FDA through the 510k pathway on March 31, 1983. Manufactured by Oscor, it is classified as a Class III device, indicating a higher level of regulatory control due to its critical function.
What It Is
The Model ZY Pacemaker Lead is a flexible wire that connects a pacemaker to the heart muscle, allowing the device to deliver electrical impulses that regulate heartbeats. It is typically implanted during a surgical procedure and is designed to withstand the mechanical stresses of the cardiac environment. The lead ensures that the pacemaker can effectively monitor and respond to the heart's electrical activity.
Clinical Applications
This pacemaker lead is commonly used in cardiology, particularly in patients with bradycardia or other arrhythmias requiring pacing support. It is utilized in both hospital and outpatient settings, often during procedures performed by electrophysiologists or cardiothoracic surgeons. The device is suitable for a wide range of patient populations, including those with congenital heart conditions or post-myocardial infarction complications.
Indications for Use
The FDA indications for the Model ZY Pacemaker Lead include its use in patients who require cardiac pacing due to conditions like heart block or sick sinus syndrome. It is intended for individuals who need assistance in maintaining an adequate heart rate.
Practical Considerations
When selecting a pacemaker lead, considerations include the lead's length and compatibility with the specific pacemaker model. Proper implantation technique is crucial to ensure optimal performance and longevity of the device. Clinicians should be familiar with the handling and insertion techniques specific to this lead model.
Frequently Asked Questions
What is Model ZY Pacemaker Lead used for?
It is used to connect a pacemaker to the heart, enabling the device to deliver electrical impulses that regulate heartbeats.
What specialties typically use this device?
Cardiologists, particularly electrophysiologists and cardiothoracic surgeons, typically use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to conditions like heart block or sick sinus syndrome.
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.