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permanent pacing lead model refino model refino-r ru rju
Oscor
Summary: The permanent pacing lead model Refino by Oscor is a device used in cardiac pacing. It is primarily utilized by cardiologists to manage heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K040569 ↗
Decision Date
April 7, 2004
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Refino pacing lead by Oscor was cleared via the FDA 510(k) pathway on April 7, 2004. It is classified as a Class III device under product code DTB.
What It Is
The Refino pacing lead is a medical device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is implanted in patients who require permanent cardiac pacing due to arrhythmias or heart block. The lead connects to a pacemaker, which regulates the heart's rhythm by sending electrical signals via the lead.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology and interventional cardiology settings. It is indicated for patients with symptomatic bradycardia, heart block, or other conditions requiring permanent pacing. The device is typically used in hospital settings during pacemaker implantation procedures.
Indications for Use
The FDA indications for the Refino pacing lead include use in patients who need permanent pacing due to heart rhythm disorders such as bradycardia or heart block. It is intended for those who require consistent electrical stimulation to maintain heart function.
Practical Considerations
The Refino pacing lead comes in various lengths to accommodate different patient anatomies. It is compatible with most modern pacemakers and requires careful placement to ensure optimal function and minimize complications. Clinicians should be familiar with lead implantation techniques and potential adjustments post-implantation.
Frequently Asked Questions
What is the permanent pacing lead model Refino used for?
It is used to deliver electrical impulses to the heart for patients requiring permanent pacing due to arrhythmias or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and interventional cardiology, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing permanent 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.