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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 ?
510(k)
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.
FDA-Cleared Indications
- For analyzing the electrical performance of atrioventricular pacemaker systems.
- For testing pacemaker leads and cardiac electrical signals during implantation or evaluation.
- For helping clinicians assess and adjust pacemaker system function.
Clinical Applications
- Testing pacemaker function during pacemaker implantation.
- Evaluating pacing and sensing performance of connected pacemaker leads.
- Assessing pacemaker operation during follow-up examinations.
- Helping clinicians verify or adjust pacemaker system settings based on measured cardiac signals.
Practical Considerations
- The analyzer is connected to the pacemaker system and leads during testing; compatibility must be confirmed for the specific pacemaker and lead configuration.
- Use requires trained cardiology or electrophysiology personnel familiar with pacemaker testing and programming.
- The device is an external analyzer, not an implanted pacemaker or permanent treatment device.
- Calibration, electrical safety checks, and maintenance should follow the applicable manufacturer instructions and institutional procedures.
- The available FDA record does not establish MRI safety for the analyzer; it should not be used in or brought into the MRI environment unless current labeling specifically permits it.
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.