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model 5311b a-v pacing system analyzer
Medtronic Vascular
Summary: The Model 5311b A-V Pacing System Analyzer by Medtronic Vascular is used to evaluate the performance of pacemakers. It is primarily utilized by cardiologists and electrophysiologists in clinical settings.
FDA Clearance Information
Pathway 510K
Number K910595 ↗
Decision Date May 7, 1991
Product Code DTC
Device Class Class 2
Evidence 0 studies
The Model 5311b A-V Pacing System Analyzer was cleared through the FDA 510k pathway on May 7, 1991. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DTC.
What It Is
The Model 5311b A-V Pacing System Analyzer is a diagnostic tool designed to assess the functionality of atrioventricular pacemakers. It measures parameters such as pacing thresholds, lead impedance, and sensing capabilities. This device is essential for ensuring the optimal performance of pacemakers and is used during implantation and follow-up evaluations.
Clinical Applications
This device is commonly used in cardiology and electrophysiology departments, particularly during pacemaker implantation and routine follow-up visits. It helps in verifying the correct operation of the pacemaker and adjusting settings as needed. The analyzer is crucial for adult and pediatric patients who rely on pacemakers for cardiac rhythm management.
Indications for Use
The device is indicated for use in patients who require pacemaker implantation or have existing pacemakers. It assists in the assessment and optimization of pacemaker function, ensuring effective cardiac pacing therapy.
Practical Considerations
The Model 5311b is compatible with a variety of pacemaker models. Clinicians should be familiar with the specific settings and configurations of the pacemakers they are evaluating. Regular calibration and maintenance of the analyzer are recommended to ensure accurate measurements.
Frequently Asked Questions
What is the Model 5311b A-V Pacing System Analyzer used for?
It is used to evaluate and optimize the performance of atrioventricular pacemakers.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for assessing and optimizing pacemaker function in patients requiring cardiac pacing.
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.