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polysafe implant pacing leads w tined fixa tip
Cardiac Control Systems
Summary: The Polysafe Implant Pacing Leads with Tined Fixa Tip are used in cardiac pacing procedures to ensure stable lead placement in the heart. They are primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K883016 ↗
Decision Date
September 16, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Polysafe Implant Pacing Leads were cleared through the FDA 510(k) pathway on September 16, 1988, by Cardiac Control Systems. This device is classified as Class III under the product code DTB.
What It Is
The Polysafe Implant Pacing Leads with Tined Fixa Tip are medical devices used in cardiac pacing. These leads are designed to be implanted in the heart to deliver electrical impulses that regulate heartbeats. The tined fixa tip helps secure the lead in place, reducing the risk of dislodgement. This is crucial for patients requiring consistent cardiac pacing.
Clinical Applications
These pacing leads are commonly used in procedures involving the implantation of pacemakers, particularly in patients with arrhythmias or heart block. They are used in hospital settings, primarily by cardiologists and electrophysiologists. The leads are suitable for adult patients who require long-term pacing support.
Indications for Use
The FDA indications suggest that these leads are intended for patients who need cardiac pacing due to conditions like bradycardia or heart block. They help maintain an adequate heart rate by delivering electrical impulses to the heart.
Practical Considerations
The Polysafe Implant Pacing Leads are available in various lengths to accommodate different patient anatomies. They are compatible with most pacemaker generators. Proper implantation technique is critical to ensure stability and function, and clinicians should be trained in lead placement.
Frequently Asked Questions
What is Polysafe Implant Pacing Leads used for?
They are used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The leads are 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.