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p3imrt tm
Adac Laboratories
Summary: The p3imrt tm is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to facilitate efficient dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K002237 ↗
Decision Date
February 2, 2001
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The p3imrt tm was cleared through the FDA 510k pathway on February 2, 2001. Manufactured by Adac Laboratories, it is classified as a Class 2 device under product code MUJ.
What It Is
The p3imrt tm is a specialized medical device designed to assist in dialysis access procedures. It is used to create or maintain vascular access for hemodialysis, a critical component for patients with renal failure. The device ensures reliable and efficient access to the bloodstream, which is essential for the dialysis process.
Clinical Applications
This device is commonly used in nephrology and vascular surgery settings to facilitate dialysis in patients with chronic kidney disease. It is particularly useful in outpatient dialysis centers and hospitals where regular dialysis treatments are performed. The p3imrt tm is suitable for adult patients requiring long-term dialysis access.
Indications for Use
The FDA indications for the p3imrt tm involve its use in creating or maintaining vascular access for dialysis. It is intended for patients who need regular hemodialysis due to kidney failure or other related conditions.
Practical Considerations
The p3imrt tm typically comes in various sizes to accommodate different patient anatomies. It is compatible with standard dialysis equipment and requires careful handling during insertion to ensure proper placement and function.
Frequently Asked Questions
What is p3imrt tm used for?
The p3imrt tm is used to create and maintain vascular access for hemodialysis in patients with renal failure.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for creating or maintaining vascular access for patients requiring hemodialysis.
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.