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new extrusion vendor for polyurethane tubing
Telectronics Pacing Systems
Summary: This is a polyurethane tubing used in medical devices, primarily for pacing systems. It is utilized by cardiologists and other specialists involved in cardiac care.
FDA Clearance Information
Pathway
510K
Number
K914489 ↗
Decision Date
August 17, 1992
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on August 17, 1992, by Telectronics Pacing Systems. It is classified as a Class III device under product code DTB.
What It Is
The new extrusion vendor for polyurethane tubing is a component used in the manufacturing of medical devices, particularly those involved in cardiac pacing. Polyurethane is chosen for its durability and flexibility, making it suitable for long-term implantation. This tubing serves as an insulating and protective layer for electrical leads used in pacemakers and other cardiac devices.
Clinical Applications
This tubing is commonly used in the production of pacemaker leads, which are essential in the management of arrhythmias. Cardiologists and electrophysiologists in hospital settings frequently employ devices containing this tubing for patients requiring cardiac pacing. It is particularly relevant for patients with bradycardia or heart block who need reliable, long-term pacing solutions.
Indications for Use
The FDA indications suggest that this tubing is intended for use in devices that require durable, biocompatible insulation, such as pacemaker leads. It is suitable for patients needing cardiac rhythm management.
Practical Considerations
Clinicians should be aware of the tubing's compatibility with existing pacing systems and its sizing options, which should match the specific requirements of the device being manufactured. Proper handling and implantation techniques are crucial to ensure the longevity and effectiveness of the device.
Frequently Asked Questions
What is new extrusion vendor for polyurethane tubing used for?
It is used as an insulating and protective component in cardiac pacing devices such as pacemaker leads.
What specialties typically use this device?
Cardiologists and electrophysiologists who manage patients with cardiac arrhythmias and require pacing solutions.
What are the FDA-cleared indications?
The tubing is indicated for use in cardiac pacing systems, providing insulation and protection for electrical leads in pacemakers.
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.