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oscor medical fix screw pacing lead peelable cath
Oscor Medical
Summary: The Oscor Medical Fix Screw Pacing Lead is a medical device used in cardiac pacing procedures. It is primarily utilized by cardiologists and electrophysiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K861493 ↗
Decision Date
August 28, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Oscor Medical Fix Screw Pacing Lead was cleared through the FDA 510(k) pathway on August 28, 1986. It is manufactured by Oscor Medical and classified as a Class III device, under product code DTB.
What It Is
The Oscor Medical Fix Screw Pacing Lead is a specialized lead used in cardiac pacing systems. It features a screw mechanism that allows for secure attachment to the heart tissue, ensuring reliable electrical conduction for pacing. This device is crucial for patients with arrhythmias or heart block who require consistent cardiac rhythm management.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers, particularly in settings such as cardiac catheterization labs or operating rooms. It is frequently employed by cardiologists and electrophysiologists to manage conditions like bradycardia or heart block in adult and geriatric patients. Its design facilitates stable and long-term pacing lead placement.
Indications for Use
The FDA indications suggest this device is intended for patients who need cardiac pacing due to conditions like bradycardia or heart block. It is suitable for those who require a reliable mechanism to maintain heart rhythm.
Practical Considerations
The Oscor Medical Fix Screw Pacing Lead typically comes in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Clinicians should be familiar with the screw-in technique to ensure proper lead fixation and function.
Frequently Asked Questions
What is the Oscor Medical Fix Screw Pacing Lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block, providing reliable electrical conduction to maintain heart rhythm.
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 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.