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implant pacing lead tined 3390 modification
Oscor Medical
Summary: The Implant Pacing Lead Tined 3390 Modification by Oscor Medical is a cardiac pacing lead used in patients requiring cardiac pacing. It is typically utilized by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K913203 ↗
Decision Date
September 23, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Implant Pacing Lead Tined 3390 Modification was cleared through the FDA 510(k) pathway on September 23, 1991. Manufactured by Oscor Medical, it is classified as a Class III device.
What It Is
The Implant Pacing Lead Tined 3390 Modification is a specialized lead used in cardiac pacing systems. It is designed to deliver electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. The tined design helps secure the lead in place within the heart tissue, minimizing dislodgement.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically use it in hospital settings, including operating rooms and cardiac catheterization labs. It is suitable for adult patients who require long-term cardiac pacing.
Indications for Use
The FDA indications suggest this device is for patients who need cardiac pacing due to conditions like slow heart rate or heart block. It helps maintain adequate heart rhythm and cardiac output.
Practical Considerations
The lead comes in various lengths to accommodate different patient anatomies and is compatible with most modern pacemakers. Proper technique during implantation is crucial to ensure optimal positioning and function.
Frequently Asked Questions
What is the Implant Pacing Lead Tined 3390 Modification used for?
It is used for delivering electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm in patients with conditions like bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients who require cardiac pacing due to conditions such as slow heart rate 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.