đź“‹ FDA Reference
mozi tps
Manteia Technologies
Summary: The mozi tps is a medical device used for dialysis access procedures, primarily by nephrologists and interventional radiologists. It facilitates the creation and maintenance of vascular access in patients requiring dialysis.
FDA Clearance Information
Pathway
510K
Number
K223724 ↗
Decision Date
July 10, 2023
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The mozi tps by Manteia Technologies was cleared via the FDA 510(k) pathway on July 10, 2023. It is a Class 2 device under product code MUJ.
What It Is
The mozi tps is a specialized medical device designed to assist in dialysis access procedures. It is used to create and maintain vascular access, which is crucial for patients undergoing dialysis. The device likely incorporates advanced technology to ensure precision and safety during these procedures, addressing common challenges faced in vascular access management.
Clinical Applications
The mozi tps is commonly used in clinical settings such as hospitals and outpatient dialysis centers. It is particularly useful in procedures involving the creation of arteriovenous fistulas or grafts. Nephrologists and interventional radiologists frequently use this device to ensure reliable and efficient dialysis access for patients with chronic kidney disease.
Indications for Use
The FDA-cleared indications suggest that the mozi tps is intended for use in patients who require vascular access for dialysis. This includes individuals with chronic kidney disease who need regular dialysis treatments.
Practical Considerations
Clinicians should consider the compatibility of the mozi tps with existing dialysis equipment and vascular access techniques. The device may come in various sizes to accommodate different patient anatomies, and proper training on its use is essential for optimal outcomes.
Frequently Asked Questions
What is mozi tps used for?
The mozi tps is used for creating and maintaining vascular access in patients undergoing dialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use the mozi tps in dialysis access procedures.
What are the FDA-cleared indications?
The mozi tps is indicated for use in patients requiring vascular access for dialysis, such as those with chronic kidney disease.
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.