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implant pacing lead retractable modification
Oscor Medical
Summary: The implant pacing lead retractable modification by Oscor Medical is a device used in cardiac pacing procedures. It is primarily utilized by cardiologists to manage arrhythmias in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K913393 ↗
Decision Date
September 23, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on September 23, 1991. Manufactured by Oscor Medical, it is classified as a Class 3 device under product code DTB.
What It Is
The implant pacing lead retractable modification is a specialized lead used in cardiac pacing systems. It is designed to deliver electrical impulses to the heart muscle to regulate heartbeats. The retractable feature allows for easier placement and repositioning within the heart chambers, enhancing procedural efficiency and patient safety.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. It is typically employed in cardiology departments within hospitals and specialized cardiac care centers. The device is suitable for adult and geriatric populations who require long-term cardiac rhythm management.
Indications for Use
The FDA-cleared indications for this device involve its use in patients who need cardiac pacing due to conditions like slow heart rate or irregular heart rhythms. It is intended for individuals who require a reliable pacing system to maintain adequate heart function.
Practical Considerations
Clinicians should consider the compatibility of the lead with existing pacemaker systems. The retractable feature may require specific handling techniques during insertion and repositioning. Sizing options may vary, so selecting the appropriate size for the patient's anatomy is crucial.
Frequently Asked Questions
What is the implant pacing lead retractable modification used for?
It is used to deliver electrical impulses to the heart to regulate heartbeats in patients requiring pacemaker support.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients needing 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.