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slim art j-svc ind pacing lead using poly 30-283
Telectronics
Summary: The Slim Art J-SVC Ind Pacing Lead is a specialized medical device used in cardiac pacing procedures. It is primarily utilized by cardiologists to manage heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K852917 ↗
Decision Date
July 29, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Slim Art J-SVC Ind Pacing Lead, manufactured by Telectronics, was cleared through the FDA 510k pathway on July 29, 1985. It is classified as a Class 2 device under product code DYB.
What It Is
The Slim Art J-SVC Ind Pacing Lead is a type of cardiac pacing lead designed for use in cardiac pacing systems. It is inserted into the heart to deliver electrical impulses that help regulate heartbeats in patients with arrhythmias. The lead is engineered to be flexible and durable, ensuring reliable performance in the dynamic environment of the heart.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or other rhythm disorders. It is typically used in hospital settings by cardiologists and electrophysiologists. The device is suitable for adult patients who require long-term cardiac pacing support.
Indications for Use
The FDA indications suggest that this device is intended for patients who need assistance in maintaining an adequate heart rhythm. It is particularly useful for those with conditions like bradycardia, where the heart beats too slowly.
Practical Considerations
The Slim Art J-SVC Ind Pacing Lead is available in various lengths to accommodate different patient anatomies. It is compatible with a range of pacemaker generators. Clinicians should be familiar with lead placement techniques to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Slim Art J-SVC Ind Pacing Lead used for?
It is used to deliver electrical impulses to the heart to regulate heartbeats in patients with arrhythmias.
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 needing assistance in maintaining an adequate heart rhythm, particularly those with bradycardia.
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.