📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a pacemaker lead to deliver electrical stimulation to the heart in patients who require cardiac pacing.
- Use as a lead connecting an implanted pacemaker generator with cardiac tissue.
Clinical Applications
- Permanent cardiac pacing for patients with clinically indicated bradycardia or conduction disorders.
- Connection of an implanted pacemaker generator to the heart during pacemaker implantation.
- Replacement or revision of a pacemaker lead when clinically indicated.
- Placement in a cardiac electrophysiology or surgical setting using the technique appropriate for the lead configuration and intended cardiac chamber.
Practical Considerations
- The device is available in different lengths and configurations; selection depends on the intended cardiac chamber, access route, patient anatomy and pacemaker system.
- Compatibility with the pacemaker generator, connector standard and other implanted components must be confirmed before implantation.
- Lead placement requires sterile technique, imaging or electrophysiologic guidance as appropriate, and testing of electrical performance after positioning.
- MRI safety cannot be determined from the available FDA record. The lead and connected pacemaker system should be treated as not established as MRI-conditional unless current manufacturer labeling confirms otherwise.
- Potential complications include lead dislodgement, failure to capture or sense, infection, bleeding, venous thrombosis, cardiac perforation and pneumothorax; patient-specific contraindications and manufacturer instructions must be reviewed.
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.