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bipolar leads disp
Medtronic Vascular
Summary: The bipolar leads disp by Medtronic Vascular is a medical device used in cardiac procedures to monitor and deliver electrical impulses. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K772103 ↗
Decision Date
November 21, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The bipolar leads disp was cleared through the FDA 510k pathway on November 21, 1977. Manufactured by Medtronic Vascular, it is classified as a Class 3 device.
What It Is
The bipolar leads disp is a type of cardiac lead used in medical procedures to deliver electrical impulses to the heart. It consists of two electrodes that help in sensing and pacing the heart's electrical activity. This device is crucial in managing arrhythmias and is often used in conjunction with pacemakers or defibrillators.
Clinical Applications
Bipolar leads are commonly used in cardiac electrophysiology labs and during implantable cardioverter-defibrillator (ICD) or pacemaker implantation procedures. They are essential in the treatment of patients with arrhythmias, heart block, or heart failure. Cardiologists and electrophysiologists in hospital settings typically use these devices for both diagnostic and therapeutic purposes.
Indications for Use
The bipolar leads disp is indicated for patients requiring cardiac pacing or defibrillation. It is used in conditions such as bradycardia, atrial fibrillation, or ventricular tachycardia, where regulation of heart rhythm is necessary.
Practical Considerations
Bipolar leads come in various lengths and configurations to accommodate different patient anatomies and procedural needs. They are compatible with most modern pacemakers and defibrillators. Proper placement and secure fixation are crucial for optimal performance and patient safety.
Frequently Asked Questions
What is bipolar leads disp used for?
It is used for cardiac pacing and monitoring in patients with arrhythmias.
What specialties typically use this device?
Cardiology and electrophysiology specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for cardiac pacing and defibrillation in patients 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.