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ccs model av-102 implantable a-v data
Cardiac Control Systems
Summary: The CCS Model AV-102 is an implantable device used for monitoring atrioventricular (A-V) data, primarily utilized by cardiologists. It aids in managing cardiac conditions by providing critical data.
FDA Clearance Information
Pathway
510K
Number
K834342 ↗
Decision Date
February 4, 1984
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The CCS Model AV-102 was cleared through the FDA 510k pathway on February 4, 1984. Manufactured by Cardiac Control Systems, it is a Class III device under product code DTB.
What It Is
The CCS Model AV-102 is an implantable device designed to monitor atrioventricular data, providing real-time insights into cardiac function. It is typically used in patients with complex cardiac conditions requiring continuous monitoring. The device collects and transmits data on heart rhythms, aiding in the diagnosis and management of arrhythmias.
Clinical Applications
This device is commonly used in cardiology, particularly in hospital settings or specialized cardiac care centers. It is beneficial for patients with arrhythmias, heart failure, or those undergoing cardiac surgery. The device helps clinicians monitor heart function and adjust treatment plans accordingly, ensuring optimal patient outcomes.
Indications for Use
The FDA indications suggest this device is for patients needing continuous monitoring of atrioventricular data, such as those with arrhythmias or heart failure. It is particularly useful in managing complex cardiac conditions.
Practical Considerations
The device is typically available in various sizes to fit different patient anatomies. It is compatible with standard cardiac monitoring systems, and implantation requires a surgical procedure. Clinicians should be trained in its use and interpretation of the data it provides.
Frequently Asked Questions
What is the CCS Model AV-102 used for?
The CCS Model AV-102 is used for monitoring atrioventricular data in patients with cardiac conditions, providing real-time insights into heart function.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use this device, especially in settings that require continuous cardiac monitoring.
What are the FDA-cleared indications?
The device is indicated for patients needing continuous monitoring of atrioventricular data, such as those with arrhythmias or heart failure.
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.