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model jy pacemaker lead - various
Oscor
Summary: The Model JY Pacemaker Lead by Oscor is a cardiac device used to connect pacemakers to the heart, ensuring proper electrical conduction. It is primarily used by cardiologists in patients requiring pacing therapy.
FDA Clearance Information
Pathway
510K
Number
K823889 ↗
Decision Date
April 30, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model JY Pacemaker Lead was cleared through the FDA 510k pathway on April 30, 1983. Manufactured by Oscor, it is classified as a Class III device under product code DTB.
What It Is
The Model JY Pacemaker Lead is a medical device designed to facilitate the connection between a pacemaker and the heart muscle. It transmits electrical impulses from the pacemaker to the heart, ensuring that the heart beats at a regular rate. The lead is typically inserted via a minimally invasive procedure and is crucial for patients with arrhythmias or heart block.
Clinical Applications
This pacemaker lead is commonly used in cardiology, particularly in electrophysiology labs and cardiac surgery settings. It is indicated for patients with bradycardia, heart block, or other conditions requiring pacing therapy. The device is suitable for both temporary and permanent pacing, depending on the patient's condition and the clinical setting.
Indications for Use
The FDA indications suggest that the Model JY Pacemaker Lead is intended for patients who need electrical pacing support due to conditions like slow heart rate or heart block. It is used to ensure that the heart maintains an adequate rhythm.
Practical Considerations
When selecting a pacemaker lead, consider the length and compatibility with the pacemaker generator. Proper technique during insertion is crucial to avoid complications such as lead dislodgement or infection. Ensure compatibility with the patient's anatomy and the specific pacemaker model being used.
Frequently Asked Questions
What is Model JY Pacemaker Lead used for?
It is used to connect a pacemaker to the heart, ensuring proper electrical conduction for patients requiring pacing therapy.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in settings like electrophysiology labs and cardiac surgery.
What are the FDA-cleared indications?
The device is indicated for patients needing pacing support due to conditions like 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.