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slim vent unipo pacing lead using polyu 90a 30-281
Telectronics
Summary: The Slim Vent Unipo Pacing Lead is a cardiac pacing lead used in cardiac electrophysiology to deliver electrical impulses to the heart. It is typically used by cardiologists and electrophysiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K852915 ↗
Decision Date
July 29, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Slim Vent Unipo Pacing Lead was cleared through the FDA 510(k) pathway on July 29, 1985, by Telectronics. It is classified as a Class III device under product code DTB.
What It Is
The Slim Vent Unipo Pacing Lead is a medical device designed for cardiac pacing. It is a unipolar lead that connects to a pacemaker, delivering electrical impulses to stimulate the heart muscle. This device is crucial for patients with arrhythmias or heart block, helping maintain an adequate heart rate.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. It is typically used in hospital settings by cardiologists and electrophysiologists. The device is suitable for adult patients who require long-term pacing therapy.
Indications for Use
The FDA indications suggest this device is intended for patients needing cardiac pacing due to conditions like bradycardia or atrioventricular block. It helps maintain proper heart rhythm and rate in these patients.
Practical Considerations
The Slim Vent Unipo Pacing Lead may come in various lengths to accommodate different patient anatomies. It is compatible with most pacemakers designed for unipolar leads. Proper lead placement technique is crucial for optimal performance and patient outcomes.
Frequently Asked Questions
What is Slim Vent Unipo Pacing Lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like bradycardia 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.