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sea med ddd pacing system analyzer
Seamed
Summary: The Sea Med DDD Pacing System Analyzer is a medical device used to evaluate and optimize cardiac pacing systems. It is typically used by cardiologists and electrophysiologists in clinical settings.
FDA Clearance Information
Pathway 510K
Number K851900 ↗
Decision Date July 19, 1985
Product Code DTC
Device Class Class 2
Evidence 0 studies
The Sea Med DDD Pacing System Analyzer was cleared through the FDA 510k pathway on July 19, 1985. Manufactured by Seamed, it is classified as a Class 2 device under product code DTC.
What It Is
The Sea Med DDD Pacing System Analyzer is a diagnostic tool designed to assess and optimize the function of dual-chamber pacemakers. It measures parameters such as pacing thresholds, lead impedance, and sensing capabilities. This device is crucial for ensuring that pacemakers are functioning correctly and efficiently, providing vital support for patients with cardiac arrhythmias.
Clinical Applications
This device is commonly used in cardiology and electrophysiology departments during the implantation and follow-up of pacemakers. It is particularly valuable in settings where precise adjustments to pacemaker settings are needed, such as during initial implantation or routine check-ups. The analyzer is used for patients with conditions like bradycardia or heart block, where pacing support is essential.
Indications for Use
The FDA indications suggest that this device is intended for use in patients requiring evaluation and optimization of dual-chamber pacing systems. It is suitable for individuals with cardiac arrhythmias needing pacemaker support.
Practical Considerations
The Sea Med DDD Pacing System Analyzer is typically compatible with a range of dual-chamber pacemakers. Clinicians should ensure proper connection and calibration before use. Familiarity with the device's interface and settings is essential for accurate assessment and optimization.
Frequently Asked Questions
What is the Sea Med DDD Pacing System Analyzer used for?
It is used to evaluate and optimize the function of dual-chamber pacemakers, ensuring they are working correctly.
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 the evaluation and optimization of dual-chamber pacing systems in patients with cardiac arrhythmias.
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.