đź“‹ FDA Reference
model 5013 transvenous ventricular pacing lead
Medtronic Vascular
Summary: The Model 5013 Transvenous Ventricular Pacing Lead is a cardiac device used to deliver electrical impulses to the heart's ventricles. It is primarily used by cardiologists in patients requiring ventricular pacing.
FDA Clearance Information
Pathway
510K
Number
K874792 ↗
Decision Date
January 19, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 5013 Transvenous Ventricular Pacing Lead was cleared through the FDA 510k pathway on January 19, 1988. Manufactured by Medtronic Vascular, it is classified as a Class III device.
What It Is
The Model 5013 is a transvenous ventricular pacing lead designed to deliver electrical impulses to the ventricles of the heart, helping to maintain an adequate heart rate in patients with bradycardia or other pacing indications. It is inserted through a vein and positioned in the heart's right ventricle. The lead connects to a pacemaker, which generates the electrical impulses.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology and cardiac surgery settings. It is indicated for patients who require ventricular pacing due to conditions like complete heart block or symptomatic bradycardia. The device is typically used in hospital settings, including operating rooms and cardiac catheterization labs.
Indications for Use
The Model 5013 is indicated for patients who need ventricular pacing, such as those with heart rhythm disorders that cause slow heart rates. It helps ensure the heart beats at a regular and adequate pace.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with most modern pacemakers. Proper placement technique is crucial for optimal performance and involves fluoroscopic guidance during insertion.
Frequently Asked Questions
What is the Model 5013 Transvenous Ventricular Pacing Lead used for?
It is used to deliver electrical impulses to the heart's ventricles in patients requiring pacing support due to slow heart rhythms.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing ventricular pacing, such as those with bradycardia or complete 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.