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slim art j bip pacing lead using poly 030-2821
Telectronics
Summary: The Slim Art J Bip Pacing Lead is a cardiac pacing lead used in pacemaker systems to help manage heart rhythm disorders. It is typically used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K852918 ↗
Decision Date
July 29, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Slim Art J Bip Pacing Lead was cleared through the FDA 510(k) pathway on July 29, 1985. Manufactured by Telectronics, it is classified as a Class 2 medical device.
What It Is
The Slim Art J Bip Pacing Lead is a specialized lead used in cardiac pacing systems. It is designed to deliver electrical impulses to the heart to maintain an appropriate heart rate and rhythm. The lead is typically implanted in the heart's right atrium or ventricle and connected to a pacemaker device, which regulates the pacing based on the patient's needs.
Clinical Applications
This pacing lead is commonly used in procedures for patients with bradycardia or other arrhythmias requiring pacing support. It is primarily utilized in cardiology and electrophysiology settings, often in hospitals or specialized cardiac care centers. Patients who benefit from this device include those with heart block, sick sinus syndrome, or other conditions leading to inadequate heart rate control.
Indications for Use
The FDA indications suggest that this device is intended for patients who require cardiac pacing due to conditions like bradycardia or heart block. It is suitable for individuals who need consistent heart rate management to prevent symptoms associated with slow heart rhythms.
Practical Considerations
The Slim Art J Bip Pacing Lead comes in various lengths to accommodate different patient anatomies and is compatible with most pacemaker systems. Proper implantation technique is crucial for optimal performance, and clinicians should be familiar with lead positioning and securing methods.
Frequently Asked Questions
What is Slim Art J Bip Pacing Lead used for?
It is used for cardiac pacing in patients with heart rhythm disorders such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac care settings.
What are the FDA-cleared indications?
It 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.