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trimed plan version 2 2
Trimed Systems
Summary: The Trimed Plan Version 2 2 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
K031088 ↗
Decision Date
July 23, 2004
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Trimed Plan Version 2 2 was cleared through the FDA 510(k) pathway on July 23, 2004. Manufactured by Trimed Systems, it is classified as a Class 2 device under product code MUJ.
What It Is
The Trimed Plan Version 2 2 is a specialized device designed for use in dialysis access procedures. It assists in the creation and maintenance of vascular access, which is essential for patients undergoing dialysis. The device ensures reliable and efficient access to the bloodstream, which is critical for effective dialysis treatment.
Clinical Applications
This device is commonly used in clinical settings where dialysis access is required, such as hospitals and specialized dialysis centers. Nephrologists and vascular surgeons use it to perform procedures like arteriovenous fistula creation or maintenance. It is particularly relevant for patients with chronic kidney disease requiring long-term dialysis.
Indications for Use
The FDA indications suggest that this device is intended for patients needing dialysis access. It is suitable for those with chronic kidney disease who require regular dialysis sessions, ensuring they have a reliable vascular access point.
Practical Considerations
Clinicians should consider the compatibility of the Trimed Plan Version 2 2 with existing vascular access devices. It is important to follow recommended sizing guidelines to ensure optimal performance and patient safety during procedures.
Frequently Asked Questions
What is Trimed Plan Version 2 2 used for?
It is used in dialysis access procedures to create and maintain vascular access for dialysis treatment.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis and vascular access procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring dialysis access, particularly 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.