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model ky pacemaker lead-various modification
Oscor Medical
Summary: The Model KY Pacemaker Lead by Oscor Medical is a cardiac device used to connect pacemakers to the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K913204 ↗
Decision Date
September 23, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model KY Pacemaker Lead was cleared through the FDA 510(k) pathway on September 23, 1991. Manufactured by Oscor Medical, it is classified as a Class III device under product code DTB.
What It Is
The Model KY Pacemaker Lead is a medical device designed to transmit electrical impulses from a pacemaker to the heart muscle. It is a flexible, insulated wire that ensures the pacemaker can effectively regulate the heart's rhythm. The lead is implanted into the heart and connected to the pacemaker, which is typically placed under the skin in the chest area.
Clinical Applications
This device is commonly used in cardiology for patients with arrhythmias or heart blockages that require pacing to maintain a regular heart rhythm. It is typically used in hospital settings, particularly in cardiac catheterization labs or during surgical procedures. The patient population includes those with bradycardia, atrial fibrillation, or other conditions that necessitate pacing.
Indications for Use
The FDA indications for the Model KY Pacemaker Lead include its use in patients who require cardiac pacing due to arrhythmias or heart block. It is suitable for individuals who need a reliable connection between their pacemaker and heart.
Practical Considerations
The Model KY Pacemaker Lead comes in various lengths and configurations to accommodate different patient anatomies and surgical techniques. It is compatible with a wide range of pacemakers, and its implantation requires precise surgical technique to ensure proper placement and function.
Frequently Asked Questions
What is the Model KY Pacemaker Lead used for?
It is used to connect a pacemaker to the heart, enabling the device to regulate heart rhythm.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients needing cardiac pacing due to arrhythmias 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.