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pacer systems analyzer cordis
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 510K
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.
Clinical Applications
This device is commonly used in cardiology and electrophysiology departments during pacemaker implantation and follow-up visits. It assists in the intraoperative and postoperative assessment of pacemaker functionality. The device is particularly valuable in settings where precise measurement of pacemaker parameters is critical, such as in patients with complex cardiac conditions or those undergoing device adjustments.
Indications for Use
The Pacer Systems Analyzer Cordis is indicated for use in patients who have received or are candidates for cardiac pacemakers. It is used to ensure that the pacemaker is operating correctly and to adjust settings as needed to optimize patient outcomes.
Practical Considerations
The device is typically compatible with a wide range of pacemaker models, but clinicians should verify compatibility with specific devices. It is important to follow proper technique during testing to ensure accurate measurements. Regular calibration and maintenance of the analyzer are recommended to maintain its precision.
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.