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ccs polysafe tm endocardial pacing lead
Cardiac Control Systems
Summary: The CCS Polysafe TM Endocardial Pacing Lead is a cardiac device used for pacing the heart. It is typically used by cardiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K864601 ↗
Decision Date
January 6, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The CCS Polysafe TM Endocardial Pacing Lead was cleared through the FDA 510(k) pathway on January 6, 1987. Manufactured by Cardiac Control Systems, it is classified as a Class III device.
What It Is
The CCS Polysafe TM Endocardial Pacing Lead is a specialized lead used in cardiac pacing systems. It is designed to be placed inside the heart and deliver electrical impulses to maintain an adequate heart rate. This device is crucial for patients with arrhythmias or heart block, providing reliable pacing support.
Clinical Applications
This device is commonly used in electrophysiology and cardiology settings, particularly in hospitals and specialized cardiac centers. It is indicated for patients who require long-term pacing due to conditions like bradycardia or atrioventricular block. The device is typically implanted by cardiologists or electrophysiologists.
Indications for Use
The FDA indications suggest this device is for patients with conditions that necessitate cardiac pacing, such as slow heart rhythms or heart block. It helps maintain proper heart function by ensuring a consistent heart rate.
Practical Considerations
Clinicians should consider the lead's compatibility with existing pacing systems and the patient's specific anatomical considerations. Proper sizing and placement technique are crucial for optimal performance and patient safety.
Frequently Asked Questions
What is the CCS Polysafe TM Endocardial Pacing Lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block to maintain a regular heart rate.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital or cardiac center settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like bradycardia or heart block.
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.