📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA record available here lists only “Summary” and does not state a specific indication for use.
- Product code MUJ alone is insufficient to establish that this device is intended to create or maintain hemodialysis vascular access.
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.
Practical Considerations
- The supplied record does not identify the device type, materials, dimensions, or instructions for use.
- Do not infer compatibility with dialysis equipment, vascular-access procedures, or other devices without reviewing the original FDA clearance and manufacturer labeling.
- MRI safety, contraindications, sterilization requirements, and handling instructions are not established by the information provided.
- The device name may include a trademark or formatting variation; confirm the exact product name and manufacturer before clinical or library indexing.
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.