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ccs model bv-114 implantable endocardial bipolarpa
Cardiac Control Systems
Summary: The CCS Model BV-114 is an implantable endocardial device used primarily for cardiac rhythm management. It is typically utilized by cardiologists in patients requiring heart rhythm stabilization.
FDA Clearance Information
Pathway
510K
Number
K853294 ↗
Decision Date
December 4, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The CCS Model BV-114 was cleared through the FDA 510(k) pathway on December 4, 1985. Manufactured by Cardiac Control Systems, it is classified as a Class III device.
What It Is
The CCS Model BV-114 is an implantable endocardial bipolar pacemaker designed to manage cardiac arrhythmias. It works by delivering electrical impulses to the heart muscle to maintain an appropriate heart rate and rhythm. This device is crucial for patients with bradycardia or other rhythm disorders where the heart beats too slowly or irregularly.
Clinical Applications
This device is commonly used in cardiology, particularly in settings such as hospitals and specialized cardiac care centers. It is suitable for patients with conditions like sick sinus syndrome or atrioventricular block. The device is implanted in patients who require long-term cardiac pacing to ensure stable heart function.
Indications for Use
The FDA indications suggest this device is for patients with cardiac arrhythmias needing rhythm management. It is particularly indicated for those with slow heart rates or irregular rhythms that could lead to more serious cardiac issues.
Practical Considerations
Clinicians should consider the device's compatibility with existing cardiac management systems and the patient's specific anatomical considerations. Proper sizing and implantation technique are crucial for optimal device performance and patient outcomes.
Frequently Asked Questions
What is CCS Model BV-114 Implantable Endocardial Bipolarpa used for?
It is used for managing cardiac arrhythmias by delivering electrical impulses to stabilize heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients with cardiac arrhythmias, particularly those with slow or irregular heart rhythms.
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.