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stela model uj45 pacing leads
Ela Medical
Summary: The Stela Model UJ45 Pacing Leads by Ela Medical are used for cardiac pacing, primarily in patients requiring a pacemaker. Cardiologists and electrophysiologists typically use these leads in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K972574 ↗
Decision Date
January 8, 1998
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Stela Model UJ45 Pacing Leads were cleared through the FDA 510k pathway on January 8, 1998. Manufactured by Ela Medical, this Class 3 device is categorized under product code DTB.
What It Is
The Stela Model UJ45 Pacing Leads are medical devices used in conjunction with pacemakers to deliver electrical impulses to the heart. These leads are inserted into the heart via the venous system and are designed to ensure reliable pacing by maintaining stable contact with the heart tissue. They are crucial in managing arrhythmias and ensuring proper cardiac function.
Clinical Applications
These pacing leads are commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists in hospital settings typically perform these procedures. The device is suitable for adult patients who require long-term cardiac pacing.
Indications for Use
The FDA indications suggest that the Stela Model UJ45 Pacing Leads are intended for patients who need cardiac pacing due to conditions like slow heart rates or heart block. These leads help maintain adequate heart rhythm and function.
Practical Considerations
Clinicians should consider the compatibility of these leads with various pacemaker models. Proper sizing and positioning are crucial for optimal performance. Familiarity with venous access techniques is essential for successful implantation.
Frequently Asked Questions
What is Stela Model UJ45 Pacing Leads used for?
The leads are used for cardiac pacing in patients requiring a pacemaker to manage arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads in hospital settings.
What are the FDA-cleared indications?
The leads are indicated for patients needing 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.