đź“‹ FDA Reference
slim vent bipo pacing lead using a90 insul 30-284
Telectronics
Summary: The Slim Vent Bipo Pacing Lead is a cardiac pacing lead used in cardiac electrophysiology to manage heart rhythm disorders. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K852916 ↗
Decision Date
July 29, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Slim Vent Bipo Pacing Lead, manufactured by Telectronics, was cleared via the FDA 510(k) pathway on July 29, 1985. It is classified as a Class 2 medical device under product code DYB.
What It Is
The Slim Vent Bipo Pacing Lead is a specialized lead used in cardiac pacing systems. It is designed to deliver electrical impulses to the heart to regulate its rhythm, particularly in patients with arrhythmias. The lead is insulated with a material known as A90 Insul, which ensures durability and reliable performance within the cardiac environment.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers or defibrillators. It is utilized in settings such as cardiac catheterization labs and electrophysiology suites. The primary patient population includes individuals with bradycardia, heart block, or other conduction disorders requiring pacing support.
Indications for Use
The FDA indications suggest that this device is intended for patients who require cardiac pacing to manage arrhythmias. It is suitable for those with conditions like slow heart rates or irregular heart rhythms.
Practical Considerations
Clinicians should consider the lead's compatibility with various pacemaker models and ensure proper sizing for individual patient anatomy. Proper technique during implantation is crucial to avoid lead dislodgement and ensure optimal performance.
Frequently Asked Questions
What is the Slim Vent Bipo Pacing Lead used for?
It is used for cardiac pacing to manage arrhythmias by delivering electrical impulses to the heart.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to arrhythmias such as 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.