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polysafe ccs trifix endocardial pacing lead sv-107
Cardiac Control Systems
Summary: The Polysafe CCS Trifix Endocardial Pacing Lead SV-107 is a medical device used in cardiac pacing procedures. It is typically utilized by cardiologists for patients requiring endocardial pacing.
FDA Clearance Information
Pathway 510K
Number K853446 ↗
Decision Date January 13, 1986
Product Code DTB
Device Class Class 3
Evidence 0 studies
The Polysafe CCS Trifix Endocardial Pacing Lead SV-107 was cleared via the FDA 510k pathway on January 13, 1986. Manufactured by Cardiac Control Systems, it is classified as a Class III device.
What It Is
The Polysafe CCS Trifix Endocardial Pacing Lead SV-107 is a specialized lead used in cardiac pacing. It is designed to deliver electrical impulses to the heart's endocardial surface, helping to maintain an adequate heart rate in patients with arrhythmias. The lead is inserted through a vein and positioned inside the heart, where it connects to a pacemaker device.
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 that this device is intended for patients who need endocardial pacing due to conditions like bradycardia or heart block. It is used to ensure the heart maintains an appropriate rhythm.
Practical Considerations
The Polysafe CCS Trifix Endocardial Pacing Lead SV-107 is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker devices and requires careful insertion technique to ensure proper placement and function.
Frequently Asked Questions
What is the Polysafe CCS Trifix Endocardial Pacing Lead SV-107 used for?
It is used for delivering electrical impulses to the heart in patients requiring endocardial pacing, typically due to arrhythmias like bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients needing endocardial pacing, such as those with 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.