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xplan 2 1
Radionics
Summary: The Xplan 2 1 by Radionics is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and interventional radiologists to facilitate vascular access for dialysis patients.
FDA Clearance Information
Pathway
510K
Number
K001700 ↗
Decision Date
June 28, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Xplan 2 1 was cleared through the FDA 510(k) pathway on June 28, 2000. Manufactured by Radionics, it is classified as a Class 2 device under product code MUJ.
What It Is
The Xplan 2 1 is a specialized medical device designed to assist in creating and maintaining vascular access for dialysis. It is used to ensure that patients undergoing dialysis have reliable and efficient access to their bloodstream. The device is typically employed in procedures that require precision and reliability to minimize complications and improve patient outcomes.
Clinical Applications
Commonly used in dialysis centers and hospitals, the Xplan 2 1 is essential in procedures involving the creation of arteriovenous fistulas or grafts. Nephrologists and interventional radiologists use this device to ensure proper vascular access, which is crucial for effective dialysis treatment. It is particularly important for patients with chronic kidney disease who require regular dialysis sessions.
Indications for Use
The FDA has cleared the Xplan 2 1 for use in procedures that establish and maintain vascular access for dialysis. This means it is intended for patients who need reliable access to their bloodstream for dialysis treatments, typically those with end-stage renal disease.
Practical Considerations
The Xplan 2 1 is compatible with standard vascular access techniques and is available in various sizes to accommodate different patient anatomies. Clinicians should be familiar with its use to ensure optimal outcomes and minimize complications during vascular access procedures.
Frequently Asked Questions
What is Xplan 2 1 used for?
The Xplan 2 1 is used for creating and maintaining vascular access in dialysis patients.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use the Xplan 2 1.
What are the FDA-cleared indications?
The device is cleared for establishing and maintaining vascular access for dialysis patients.
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.