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leads utiliz volun stand 1 3 2 mm uni biopolar co
Pacesetter Systems
Summary: The Leads Utiliz Volun Stand 1 3 2 mm Uni Biopolar Co is a medical device used primarily in cardiac procedures. It is typically utilized by cardiologists in settings requiring precise electrical stimulation or monitoring.
FDA Clearance Information
Pathway
510K
Number
K861440 ↗
Decision Date
May 13, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on May 13, 1986, by Pacesetter Systems. It is classified as a Class III device under the product code DTB.
What It Is
This device is a lead used in cardiac procedures, designed for both unipolar and bipolar configurations. It facilitates electrical conduction between the heart and an external device, such as a pacemaker or defibrillator. The 1 3 2 mm specification refers to its dimensions, which are crucial for fitting within the cardiac anatomy. Its design allows for reliable performance in both acute and chronic settings.
Clinical Applications
This device is commonly used in electrophysiology labs and during cardiac surgeries. It is essential for procedures involving pacemaker or defibrillator implantation. Cardiologists and electrophysiologists use these leads to ensure proper electrical conduction in patients with arrhythmias or heart block. The device is suitable for both adult and pediatric populations, depending on the specific cardiac condition.
Indications for Use
The FDA indications suggest this device is used for patients requiring cardiac electrical stimulation or monitoring. It is suitable for conditions such as arrhythmias, heart block, or other cardiac conduction abnormalities.
Practical Considerations
The device's sizing is critical for compatibility with various cardiac devices and patient anatomies. It is important to ensure the lead is compatible with the specific pacemaker or defibrillator model being used. Proper technique during implantation is crucial to avoid dislodgement or improper positioning.
Frequently Asked Questions
What is Leads Utiliz Volun Stand 1 3 2 mm Uni Biopolar Co used for?
It is used for electrical conduction in cardiac procedures, particularly with pacemakers or defibrillators.
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 who require cardiac electrical stimulation or monitoring, 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.