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Pacer Systems Analyzer Cordis
Summary: The Pacer Systems Analyzer Cordis is a medical device used to evaluate and ensure the proper functioning of cardiac pacemakers. It is primarily used by cardiologists and electrophysiologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K760013 ↗
Decision Date ?
July 20, 1976
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The Pacer Systems Analyzer Cordis was cleared through the FDA 510(k) pathway on July 20, 1976. It is manufactured by Cordis and classified as a Class 2 medical device.
What It Is
The Pacer Systems Analyzer Cordis is a diagnostic tool designed to test and analyze the performance of cardiac pacemaker systems. It ensures that pacemakers are functioning correctly by measuring parameters such as pacing threshold, sensing threshold, and lead impedance. This device is crucial for clinicians to verify the efficacy and safety of pacemaker implantation and ongoing function.
FDA-Cleared Indications
- Use in the evaluation of cardiac pacemaker systems.
- Measurement of pacemaker system performance parameters, including pacing threshold, sensing threshold, and lead impedance.
Clinical Applications
- Testing pacemaker function during implantation.
- Assessing pacing leads and generator performance after implantation.
- Evaluating pacemaker function during follow-up visits.
- Supporting clinical adjustment of pacemaker settings based on measured system parameters.
Practical Considerations
- Compatibility should be confirmed with the specific pacemaker generator, lead system, connectors, and accessories before testing.
- Testing should be performed by trained cardiology or electrophysiology personnel using the manufacturer’s instructions.
- Proper connection and handling are important because inaccurate connections can produce unreliable measurements or affect pacing support.
- The analyzer itself is external equipment; MRI safety depends on the implanted pacemaker system and the MRI conditions, not on the analyzer alone.
- Calibration, preventive maintenance, and electrical safety checks should follow the manufacturer’s instructions and facility policy.
Frequently Asked Questions
What is the Pacer Systems Analyzer Cordis used for?
It is used to test and analyze the function of cardiac pacemakers, ensuring they are operating correctly.
What specialties typically use this device?
Cardiology and electrophysiology specialists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in evaluating and ensuring the proper function of cardiac pacemakers in patients.
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.