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permanent temporary pacemaker electr
Diag
Summary: The permanent temporary pacemaker electrode by Diag is used to provide temporary cardiac pacing in patients with arrhythmias. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K820262 ↗
Decision Date
March 12, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 12, 1982, by the manufacturer Diag. It is classified as a Class III device under product code DTB.
What It Is
This device is a temporary pacemaker electrode designed to deliver electrical impulses to the heart to maintain an adequate heart rate and rhythm. It is typically used in situations where the heart's natural pacemaker is not functioning properly. The electrode is inserted into the heart via a vein and connected to an external pacemaker device.
Clinical Applications
Commonly used in emergency and perioperative settings, this device is crucial for managing acute arrhythmias, especially in patients with bradycardia or heart block. It is frequently used in cardiology and cardiac surgery departments. The device is suitable for adult and pediatric patients requiring temporary pacing support.
Indications for Use
The device is indicated for temporary pacing in patients with cardiac arrhythmias, such as bradycardia or heart block, where immediate pacing is necessary to maintain cardiac output.
Practical Considerations
The electrode is available in various lengths to accommodate different patient anatomies and is compatible with most external pacemaker devices. Proper insertion technique is crucial to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is the permanent temporary pacemaker electrode used for?
It is used for temporary cardiac pacing in patients with arrhythmias to maintain heart rate and rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for temporary pacing in patients with arrhythmias, such as 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.