đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Cardiac pacing for patients with symptomatic bradycardia or other slow heart-rate disorders.
- Pacing for rhythm disturbances associated with sick sinus syndrome.
- Pacing for atrioventricular conduction block when indicated for permanent cardiac pacing.
Clinical Applications
- Permanent endocardial cardiac pacing for selected patients with clinically significant bradycardia.
- Treatment of pacing needs related to sick sinus syndrome.
- Treatment of pacing needs related to atrioventricular block.
- Implantation by qualified cardiac specialists in a hospital or cardiac electrophysiology setting.
Practical Considerations
- The available FDA record identifies the device as an implantable endocardial bipolar pacemaker; exact lead configuration, dimensions, longevity and implantation specifications should be confirmed in the original labeling.
- The device requires compatibility assessment with the selected pacing leads, programmer, generator system and other implanted cardiac equipment.
- Implantation requires venous access and fluoroscopic or other imaging guidance, with lead placement in the appropriate cardiac chamber according to the pacing indication.
- MRI safety cannot be determined from the available record. Do not assume the device is MRI-conditional; verify the original labeling and the complete implanted system before MRI.
- Contraindications, device handling instructions, follow-up requirements and replacement criteria should be taken from the manufacturer’s labeling and the implanting cardiology team.
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.