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oscor medical fix screw pac lead peel cath modif
Oscor Medical
Summary: The Oscor Medical Fix Screw Pac Lead Peel Cath Modif is a Class III medical device used in cardiac procedures. It is primarily utilized by cardiologists and electrophysiologists for lead placement in pacemaker and defibrillator implantations.
FDA Clearance Information
Pathway
510K
Number
K913205 ↗
Decision Date
September 23, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on September 23, 1991, under the product code DTB. It is manufactured by Oscor Medical and classified as a Class III device.
What It Is
This device is a specialized lead used in cardiac procedures, specifically for the placement of pacemaker or defibrillator leads. It features a screw mechanism that allows for secure attachment to the heart tissue, ensuring stable lead placement. The peel-away catheter modification facilitates easier lead insertion and positioning during implantation.
Clinical Applications
The device is commonly used in cardiac electrophysiology labs and operating rooms during pacemaker or implantable cardioverter-defibrillator (ICD) implantation procedures. It is typically employed by cardiologists and electrophysiologists to ensure precise lead placement in patients requiring cardiac rhythm management. The device is suitable for a wide range of patients, including those with bradycardia or heart block.
Indications for Use
The device is indicated for use in patients who require cardiac pacing or defibrillation. It is specifically designed for those needing stable lead placement in the heart, often due to conditions like arrhythmias or heart failure.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard pacemaker and ICD systems. Clinicians should be familiar with the screw-in lead technique and the use of peel-away sheaths for optimal results.
Frequently Asked Questions
What is Oscor Medical Fix Screw Pac Lead Peel Cath Modif used for?
It is used for the placement of pacemaker or defibrillator leads in cardiac procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac rhythm management procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing or defibrillation, particularly for stable lead placement in the heart.
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.