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pacing lead model bus 860 bus 890
R.E. Brown
Summary: The pacing lead model BUS 860/890 by R.E. Brown is a medical device used in cardiac pacing procedures. It is primarily used by cardiologists and electrophysiologists to manage heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K781624 ↗
Decision Date
December 21, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacing lead model BUS 860/890 was cleared by the FDA through the 510(k) pathway on December 21, 1978. It is manufactured by R.E. Brown and is classified as a Class III device under product code DTB.
What It Is
The pacing lead model BUS 860/890 is a component of a cardiac pacemaker system. It is designed to deliver electrical impulses to the heart muscle to regulate heartbeats. The lead is typically inserted into the heart via a vein and connected to a pacemaker device, which controls the pacing based on the patient's cardiac needs.
Clinical Applications
This device is commonly used in procedures to treat bradycardia, where the heart beats too slowly. It is utilized in both inpatient and outpatient settings, often in cardiology and electrophysiology departments. The device is suitable for adult patients who require long-term cardiac pacing due to conditions such as sick sinus syndrome or atrioventricular block.
Indications for Use
The FDA indications suggest that this device is intended for patients who need assistance in maintaining a regular heart rhythm. It is specifically used for those with conditions that cause abnormally slow heart rates, ensuring adequate cardiac output.
Practical Considerations
The pacing lead is available in various lengths to accommodate different patient anatomies. It is compatible with most standard pacemaker generators. Clinicians should be familiar with the insertion technique, which requires fluoroscopic guidance to ensure proper placement within the heart.
Frequently Asked Questions
What is the pacing lead model BUS 860/890 used for?
It is used to deliver electrical impulses to the heart to regulate heartbeats in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients needing assistance to maintain a regular heart rhythm due to conditions like bradycardia.
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.