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model 5866-24 pacemaker lead adaptor
Medtronic Vascular
Summary: The model 5866-24 pacemaker lead adaptor by Medtronic Vascular is used to connect pacemaker leads to pulse generators. It is primarily used by cardiologists and electrophysiologists in cardiac procedures.
FDA Clearance Information
Pathway
510K
Number
K864856 ↗
Decision Date
January 6, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 5866-24 pacemaker lead adaptor was cleared through the FDA 510(k) pathway on January 6, 1987. Manufactured by Medtronic Vascular, it is classified as a Class III medical device.
What It Is
The model 5866-24 pacemaker lead adaptor is a medical device designed to facilitate the connection between pacemaker leads and pulse generators. It ensures compatibility and secure attachment, which is crucial for the effective functioning of a pacemaker system. This adaptor plays a vital role in cardiac rhythm management by ensuring that electrical impulses are properly transmitted from the pacemaker to the heart.
Clinical Applications
This adaptor is commonly used in cardiac procedures involving the implantation of pacemakers. It is particularly relevant in cases where existing pacemaker leads need to be connected to newer pulse generators, often seen in device upgrades or replacements. Cardiologists and electrophysiologists in hospital settings are the primary users, dealing with patients requiring long-term cardiac rhythm management.
Indications for Use
The FDA indications suggest that this device is intended for patients who require a pacemaker for cardiac rhythm management. It is used to ensure proper connection between the pacemaker leads and the pulse generator, which is essential for patients with arrhythmias or other heart rhythm disorders.
Practical Considerations
The model 5866-24 pacemaker lead adaptor is designed to be compatible with a variety of pacemaker leads and pulse generators. Clinicians should ensure compatibility with existing systems during device upgrades. Proper technique in securing the adaptor is crucial to prevent dislodgement and ensure reliable device function.
Frequently Asked Questions
What is the model 5866-24 pacemaker lead adaptor used for?
It is used to connect pacemaker leads to pulse generators, ensuring proper cardiac rhythm management.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring pacemaker lead connections to pulse generators for cardiac rhythm management.
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.