đź“‹ FDA Reference
3 2mm unipolar bipolar lead connectors vs-1
Oscor Medical
Summary: The 3 2mm unipolar bipolar lead connectors by Oscor Medical are used in cardiac procedures to connect leads to pacemakers or other cardiac devices. They are primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K862966 ↗
Decision Date
October 31, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on October 31, 1986, by Oscor Medical. It is classified as a Class 3 device under product code DTB.
What It Is
The 3 2mm unipolar bipolar lead connectors are medical devices designed to facilitate the connection of cardiac leads to pacemakers or defibrillators. These connectors ensure reliable electrical conduction between the cardiac device and the heart tissue. They are essential components in cardiac rhythm management, providing a stable interface for lead attachment.
Clinical Applications
These connectors are commonly used in cardiac procedures involving pacemakers or implantable cardioverter-defibrillators (ICDs). They are utilized in settings such as hospitals and specialized cardiac centers, primarily by cardiologists and electrophysiologists. The device is suitable for patients requiring cardiac rhythm management, including those with arrhythmias or heart failure.
Indications for Use
The device is indicated for use in patients who require cardiac pacing or defibrillation. This includes individuals with arrhythmias, heart block, or other conditions that necessitate the use of a pacemaker or ICD.
Practical Considerations
The connectors are designed to be compatible with standard cardiac leads and devices. Clinicians should ensure proper sizing and secure attachment to prevent lead dislodgement. Familiarity with the specific connection technique is essential for optimal performance.
Frequently Asked Questions
What is 3 2mm unipolar bipolar lead connectors used for?
They are used to connect cardiac leads to pacemakers or defibrillators, ensuring reliable electrical conduction.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac rhythm management procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing or defibrillation, such as those with arrhythmias 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.