đź“‹ FDA Reference
model 5866-34a pacemaker lead adaptor
Medtronic Vascular
Summary: The model 5866-34a pacemaker lead adaptor is a device used to connect pacemaker leads to pulse generators. It is primarily used by cardiologists and electrophysiologists in settings where pacemaker implantation or maintenance is performed.
FDA Clearance Information
Pathway 510K
Number K883203 ↗
Decision Date September 6, 1988
Product Code DTB
Device Class Class 3
Evidence 0 studies
The model 5866-34a pacemaker lead adaptor by Medtronic Vascular was cleared through the FDA 510k pathway on September 6, 1988. It is classified as a Class III device under product code DTB.
What It Is
The model 5866-34a is a pacemaker lead adaptor designed to facilitate the connection between pacemaker leads and pulse generators. This adaptor ensures a secure and reliable electrical connection, which is crucial for the proper functioning of the pacemaker system. It is an essential component in the setup and maintenance of cardiac pacing systems.
Clinical Applications
This adaptor is commonly used in cardiac procedures involving the implantation or replacement of pacemaker systems. It is utilized in electrophysiology labs and cardiac surgery settings, primarily by cardiologists and electrophysiologists. The device is suitable for adult and pediatric patients requiring pacemaker therapy for conditions such as bradycardia or heart block.
Indications for Use
The adaptor is indicated for use in patients who require pacemaker therapy to manage arrhythmias or other cardiac conduction disorders. It is specifically designed to connect pacemaker leads to pulse generators, ensuring effective pacing therapy.
Practical Considerations
The model 5866-34a adaptor is compatible with a range of pacemaker leads and pulse generators, but clinicians should verify compatibility with specific models. Proper technique during connection is essential to ensure a secure fit and optimal device performance.
Frequently Asked Questions
What is the model 5866-34a pacemaker lead adaptor used for?
It is used to connect pacemaker leads to pulse generators, ensuring effective pacing therapy.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac procedures.
What are the FDA-cleared indications?
The adaptor is indicated for connecting pacemaker leads to pulse generators in patients requiring pacemaker therapy.
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.