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medtronic model 5866-36 lead adaptor kit
Medtronic Vascular
Summary: The Medtronic Model 5866-36 Lead Adaptor Kit is a medical device used to connect different types of leads in cardiac procedures. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K881712 ↗
Decision Date
May 25, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 5866-36 Lead Adaptor Kit was cleared via the FDA 510(k) pathway on May 25, 1988. It is manufactured by Medtronic Vascular and is classified as a Class 3 device under product code DTB.
What It Is
The Medtronic Model 5866-36 Lead Adaptor Kit is designed to facilitate the connection between different types of cardiac leads and devices. This adaptor is crucial in ensuring compatibility between older and newer generation devices, allowing for seamless integration in cardiac pacing and defibrillation systems. The device plays a vital role in maintaining the functionality of cardiac implantable devices, which are essential for managing various cardiac conditions.
Clinical Applications
This adaptor kit is commonly used in cardiac procedures, particularly in the fields of cardiology and electrophysiology. It is utilized in hospital settings, especially in cardiac catheterization labs and during implantable cardioverter-defibrillator (ICD) or pacemaker implantation procedures. The device is critical for ensuring that leads from different manufacturers or generations can be used together, thus providing flexibility in device management for patients with complex cardiac needs.
Indications for Use
The FDA indications suggest that this device is intended for use in patients who require cardiac pacing or defibrillation and where lead compatibility issues may arise. It is particularly useful in cases where existing leads need to be connected to new devices.
Practical Considerations
The Medtronic Model 5866-36 Lead Adaptor Kit is typically available in standard sizes to fit a variety of leads. Clinicians should ensure compatibility with both the leads and the cardiac device being used. Proper technique in securing the adaptor is crucial to prevent lead dislodgement or connection failure.
Related Literature
The linked study evaluated the performance of different nasal cannulas in neonatal noninvasive ventilation (NIV) using a novel model. It compared the inspiratory pressure at the ventilator with the pressure delivered at the nares across three cannula brands. The study highlighted differences in pressure delivery, which could impact clinical outcomes in neonatal care. However, the study's focus on neonatal models limits its direct applicability to adult or general populations.
Frequently Asked Questions
What is the Medtronic Model 5866-36 Lead Adaptor Kit used for?
It is used to connect different types of cardiac leads to implantable devices, ensuring compatibility and functionality in cardiac pacing and defibrillation.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device, especially in hospital settings during cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring cardiac pacing or defibrillation where lead compatibility is an issue.
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.