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medtronic model 5311b a-v pacing system analyzer
Medtronic Vascular
Summary: The Medtronic Model 5311B A-V Pacing System Analyzer is a medical device used to evaluate and optimize pacemaker function. It is primarily used by cardiologists and electrophysiologists during pacemaker implantation and follow-up procedures.
FDA Clearance Information
Pathway
510K
Number
K884331 ↗
Decision Date
January 10, 1989
Product Code
DTC
Device Class
Class 2
Evidence
0 studies
The Medtronic Model 5311B A-V Pacing System Analyzer was cleared through the FDA 510(k) pathway on January 10, 1989. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DTC.
What It Is
The Medtronic Model 5311B A-V Pacing System Analyzer is a diagnostic tool designed to assess the performance of pacemakers. It measures and analyzes the electrical signals of the heart and the pacemaker, ensuring proper device function and patient safety. This device is crucial for verifying the correct settings and operation of pacemakers during implantation and routine check-ups.
Clinical Applications
This device is commonly used in cardiology and electrophysiology settings, particularly during pacemaker implantation and follow-up visits. It helps clinicians ensure that the pacemaker is functioning correctly and is appropriately synchronized with the patient's cardiac activity. It is used in hospital settings, outpatient clinics, and specialized cardiac centers, primarily for patients with arrhythmias or heart block requiring pacemaker support.
Indications for Use
The device is indicated for use in patients who have or are receiving a pacemaker. It is used to test and optimize pacemaker settings, ensuring that the device is functioning correctly and meeting the patient's cardiac needs.
Practical Considerations
The analyzer is compatible with various pacemaker models and typically requires connection to the pacemaker leads during testing. Clinicians should be familiar with the specific pacemaker model being used to ensure accurate analysis and adjustment. Regular calibration and maintenance of the analyzer are recommended to maintain accuracy.
Frequently Asked Questions
What is the Medtronic Model 5311B A-V Pacing System Analyzer used for?
It is used to evaluate and optimize the function of pacemakers, ensuring they are working correctly and safely in patients.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device during pacemaker implantation and follow-up procedures.
What are the FDA-cleared indications?
The device is indicated for use in testing and optimizing pacemaker function in patients who have or are receiving a pacemaker.
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.