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alternate packaging configuration for pacing leads
Medtronic Vascular
Summary: This device is an alternate packaging configuration for pacing leads, used in cardiac pacing procedures. It is primarily utilized by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K890527 ↗
Decision Date
April 21, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on April 21, 1989. Manufactured by Medtronic Vascular, it is classified as a Class III device under product code DTB.
What It Is
The alternate packaging configuration for pacing leads is a variation in the packaging of leads used in cardiac pacing. Pacing leads are critical components in pacemaker systems, delivering electrical impulses to the heart muscle to maintain an adequate heart rate. This configuration may offer improved handling or storage benefits, ensuring the leads remain sterile and functional until use.
Clinical Applications
Pacing leads are commonly used in procedures to implant pacemakers in patients with arrhythmias or heart block. These procedures are typically performed by cardiologists or electrophysiologists in hospital settings. The device is essential for patients who require long-term cardiac pacing support to manage heart rhythm disorders.
Indications for Use
The device is indicated for use in patients who require cardiac pacing due to conditions like bradycardia or heart block. It is suitable for individuals who need a pacemaker to regulate their heart rhythm.
Practical Considerations
Clinicians should consider the compatibility of the pacing leads with the pacemaker generator being used. The alternate packaging may offer advantages in terms of sterility and ease of use during implantation procedures.
Frequently Asked Questions
What is the alternate packaging configuration for pacing leads used for?
It is used in cardiac pacing procedures to deliver electrical impulses to the heart, helping to maintain an adequate heart rate.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is 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.