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Model Mf D Mx D Pacemaker Leads
Summary: The Model MF D MX D Pacemaker Leads by Oscor are used in cardiac pacing procedures to deliver electrical impulses to the heart. They are typically used by cardiologists in hospital settings for patients requiring pacemaker implantation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K823898 ↗
Decision Date ?
April 30, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model MF D MX D Pacemaker Leads were cleared by the FDA through the 510k pathway on April 30, 1983. Manufactured by Oscor, this device is classified as a Class III medical device.
What It Is
The Model MF D MX D Pacemaker Leads are medical devices designed to transmit electrical impulses from a pacemaker to the heart muscle. They are essential components in cardiac pacing systems and are typically inserted transvenously. The leads ensure that the heart maintains an adequate rhythm and rate, especially in patients with arrhythmias or heart block.
FDA-Cleared Indications
- Electrical stimulation of the heart in patients who require pacing to maintain an adequate heart rate.
- Use during implantation of a cardiac pacemaker system for bradycardia or other conditions causing an inadequate heart rate.
Clinical Applications
- Transvenous placement of a pacemaker lead during implantation of a cardiac pacing system.
- Delivery of electrical impulses from an implanted pacemaker generator to the heart muscle.
- Long-term cardiac pacing in patients with clinically significant slow heart rates or conduction disorders, when selected by the treating cardiology team.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator, including connector configuration and electrical specifications.
- Clinicians select lead length and configuration based on the patient’s anatomy, access route, and intended cardiac chamber.
- Placement requires imaging and electrical testing to confirm lead position, sensing, capture threshold, and lead integrity.
- MRI safety cannot be assumed from the device name alone. MRI eligibility depends on the specific lead, generator, complete implanted system, and current manufacturer and FDA labeling.
- Potential complications include bleeding, infection, venous injury, pneumothorax, cardiac perforation, lead dislodgement, loss of capture, and long-term lead malfunction.
Frequently Asked Questions
What is Model MF D MX D Pacemaker Leads used for?
These leads are used to deliver electrical impulses from a pacemaker to the heart, helping to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads during pacemaker implantation procedures.
What are the FDA-cleared indications?
The leads are indicated for patients needing electrical heart stimulation to maintain an adequate heart rate, such as those with 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.