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accufix and laserdish bipolar vs-1 leads
Telectronics And Control Pacing Systems
Summary: The Accufix and Laserdish Bipolar VS-1 Leads are medical devices used in cardiac pacing systems. They are typically utilized by cardiologists to help manage patients with cardiac arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K884811 ↗
Decision Date
February 22, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Accufix and Laserdish Bipolar VS-1 Leads were cleared through the FDA 510(k) pathway on February 22, 1989. Manufactured by Telectronics And Control Pacing Systems, these devices are classified as Class III under product code DTB.
What It Is
The Accufix and Laserdish Bipolar VS-1 Leads are components of cardiac pacing systems, designed to deliver electrical impulses to the heart to maintain an adequate heart rate. These leads are inserted into the heart via the venous system and are crucial for patients who require assistance in managing arrhythmias. Their bipolar design allows for more precise sensing and pacing capabilities.
Clinical Applications
These leads are commonly used in the context of cardiac pacing, particularly in patients with bradycardia or heart block. They are typically utilized in cardiology and electrophysiology departments within hospitals. Patients who benefit from these devices often include those with symptomatic arrhythmias that cannot be managed with medication alone.
Indications for Use
The FDA indications for the Accufix and Laserdish Bipolar VS-1 Leads are primarily for patients who require cardiac pacing due to conditions like bradycardia or heart block. These devices help maintain a regular heart rhythm in patients whose hearts are unable to do so independently.
Practical Considerations
When considering the use of these leads, clinicians should ensure compatibility with the patient's existing pacing system. Proper sizing and placement technique are crucial for optimal performance and patient safety. Regular follow-up is necessary to monitor lead function and patient response.
Frequently Asked Questions
What is Accufix and Laserdish Bipolar VS-1 Leads used for?
These leads are used in cardiac pacing systems to help manage arrhythmias by delivering electrical impulses to the heart.
What specialties typically use this device?
Cardiology and electrophysiology specialists typically use these devices in hospital settings.
What are the FDA-cleared indications?
The leads are 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.