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model mf d mx d pacemaker leads
Oscor
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
510K
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.
Clinical Applications
These pacemaker leads are commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists in hospital settings frequently use these leads during surgeries. They are suitable for adult and pediatric patients who require long-term cardiac pacing.
Indications for Use
The FDA indications suggest that these leads are intended for patients who need electrical stimulation of the heart to maintain an adequate heart rate. This includes individuals with conditions like bradycardia, heart block, or other arrhythmias that result in a slow heart rate.
Practical Considerations
When using these pacemaker leads, clinicians should consider the appropriate lead length and compatibility with the pacemaker device. Proper insertion technique is crucial to ensure optimal lead placement and function. Regular follow-up is necessary to monitor lead performance and patient response.
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.