đź“‹ FDA Reference
models 1113 and 1114 pacemaker leads
Possis Medical
Summary: The models 1113 and 1114 are pacemaker leads manufactured by Possis Medical, used in cardiac pacing systems to manage arrhythmias. They are primarily utilized by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K893763 ↗
Decision Date
July 14, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The models 1113 and 1114 pacemaker leads by Possis Medical were cleared via the FDA 510k pathway on July 14, 1989. They are classified as Class III devices under product code DTB.
What It Is
These pacemaker leads are critical components of cardiac pacing systems, designed to deliver electrical impulses from the pacemaker to the heart muscle. They help regulate heartbeats in patients with arrhythmias by ensuring proper electrical conduction. The leads are typically inserted transvenously and positioned within the heart chambers.
Clinical Applications
Pacemaker leads are commonly used in patients with bradycardia, heart block, or other conduction disorders requiring pacing. They are frequently utilized in hospital settings, particularly in cardiology departments, and are essential in procedures performed by cardiologists and electrophysiologists. The leads are suitable for both temporary and permanent pacing solutions, depending on patient needs.
Indications for Use
These pacemaker leads are indicated for patients who require cardiac pacing due to arrhythmias such as bradycardia or heart block. They are used to maintain adequate heart rate and rhythm in patients whose natural pacemaker is not functioning properly.
Practical Considerations
When selecting pacemaker leads, consider factors such as lead length and compatibility with the pacemaker generator. Proper technique during insertion is crucial to ensure optimal lead positioning and function. These leads are compatible with a range of pacemaker models, ensuring flexibility in clinical use.
Frequently Asked Questions
What is models 1113 and 1114 pacemaker leads used for?
These leads are used to deliver electrical impulses from a pacemaker to the heart, helping to regulate heartbeats in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these pacemaker leads in their practice.
What are the FDA-cleared indications?
These leads are indicated for use in 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.